Pharmaceuticals & Life Sciences — 134 Nodes
- 21 CFR Part 11 - Electronic Records; Electronic Signatures
This regulation establishes the criteria under which the U.S. Food and Drug Administration considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be… - 21 CFR Part 11 - Electronic Records; Electronic Signatures
This regulation outlines the scope, implementation, definitions, and controls for electronic records and electronic signatures in closed and open systems. - 21 CFR Part 1308 - Schedules of Controlled Substances (DEA)
DEA 21 CFR Part 1308 lists the schedules of controlled substances established under the Controlled Substances Act, placing each substance in Schedule I through Schedule V according to its abuse potential, accepted… - 21 CFR Part 203 - Prescription Drug Marketing (Samples and Wholesale Distribution)
21 CFR Part 203 implements the Prescription Drug Marketing Act and governs the sale, purchase, distribution and sampling of prescription drugs. As a general sales restriction, no person may sell, purchase or trade, or… - 21 CFR Part 205 - FDA Guidelines for State Licensing of Wholesale Prescription Drug Distributors
21 CFR Part 205 sets the minimum standards and guidelines for the state licensing of wholesale prescription drug distributors implementing the Prescription Drug Marketing Act. A wholesale distributor of prescription… - 21 CFR Part 312 - Investigational New Drug Application
This regulation establishes the requirements for submitting and maintaining an Investigational New Drug Application (IND), detailing the responsibilities of sponsors and investigators in conducting clinical trials. - 21 CFR Part 314 - Applications for FDA Approval to Market a New Drug
This regulation outlines the requirements for submitting, amending, and maintaining applications for FDA approval to market a new drug, including postmarketing reporting obligations. - 21 CFR Part 320 - Bioavailability and Bioequivalence Requirements (FDA)
FDA 21 CFR Part 320 sets the bioavailability and bioequivalence requirements for drug products, requiring applicants to submit the required data, apply the waiver criteria where appropriate, establish the basis for… - 21 CFR Part 600 - FDA Biological Products: General Standards, Records and Reporting
21 CFR Part 600 sets the general standards applicable to licensed biological products regulated by the U.S. Food and Drug Administration through the Center for Biologics Evaluation and Research. A licensed manufacturer… - 21st Century Cures Act
The 21st Century Cures Act, Section 3060, requires the FDA to prioritize the review of certain medical devices, including Software as a Medical Device (SaMD), and to establish a process for the regulation of… - Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry
This guidance provides recommendations for the use of adaptive designs in clinical trials, as outlined in Section III: Pre-Specified Adaptations, and applies to sponsors of clinical trials for drugs and biologics, as… - Applications for FDA Approval to Market a New Drug
This regulation establishes the requirements for submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) under 21 U.S.C. 355, including content, format, review timelines, and post-approval… - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
This regulation requires pharmaceutical manufacturers to assess and control DNA reactive (mutagenic) impurities in their products, as outlined in Section 1 of the ICH M7(R1) guideline, to limit potential carcinogenic… - Australian Register of Therapeutic Goods (ARTG) - Requirements for AUST R and AUST L Medicine Registration: Product Information Approval, Risk Management Plans, Classification, Quality, Safety and Efficacy Evaluation, TGA Audit System and Post-Market Review
This regulation governs the inclusion of medicines in the Australian Register of Therapeutic Goods (ARTG) under AUST R (registered) or AUST L (listed) pathways, requiring sponsors to demonstrate quality, safety, and… - Biological Products: General; and Licensing
The FDA 21 CFR Parts 600-601 regulation requires manufacturers of biological products to submit a Biologics License Application (BLA) and comply with lot release testing and approval standards, as outlined in Section… - Biologics Price Competition and Innovation Act of 2009
The FDA 351(k) biosimilar pathway requires that an applicant demonstrate biosimilarity to a reference product, as outlined in Section 351(k) of the Public Health Service Act. This applies to manufacturers of biosimilar… - Biosimilar Development: Comparability Exercise, Quality Comparability, Non-Clinical Studies, Clinical PK/PD Studies, Efficacy/Safety and Immunogenicity Assessment
This guideline outlines the scientific principles for demonstrating biosimilarity between a proposed biosimilar and its reference biological medicinal product through a stepwise comparability exercise. It applies to… - Brazil ANVISA Good Manufacturing Practices RDC 658/2022 - Pharmaceutical GMP, AFE Certification and Inspection
Brazil's Resolucao da Diretoria Colegiada RDC 658 of 30 March 2022 (ANVISA Good Manufacturing Practices for Medicines) established updated GMP requirements for finished pharmaceutical products aligned with ICH Q10… - Brazil Law 6360 of 1976 Health Surveillance of Drugs Medicines Cosmetics and Sanitary Products ANVISA Drug Registration Manufacturing Authorisation and RDC Resolutions Framework
Brazil Law No. 6.360 of 23 September 1976 establishes the foundational legal framework for health surveillance of drugs medicines cosmetics sanitary products and related items administered by Agência Nacional de… - Canada Food and Drugs Act 1985
The Food and Drugs Act (R.S.C. 1985, c. F-27), consolidated and continuously amended, prohibits the sale of a food that is adulterated, unfit for human consumption, or misleadingly labelled under Section 4, requires a… - Canada Natural Health Products Regulations 2003 - NPN Product Licence, GMP Site Licence and Health Canada Compliance
Canada's Natural Health Products Regulations SOR/2003-196 (NHPR, in force January 1, 2004, under the Food and Drugs Act R.S.C. 1985 c. F-27) created a comprehensive licensing regime for natural health products (NHPs)… - China NMPA Drug Registration Regulation 2020 - Marketing Authorisation Holder System and Priority Review
China's Drug Registration Regulation (Order No. 27, 1 July 2020) issued by the National Medical Products Administration (NMPA - formerly CFDA) establishes the Marketing Authorisation Holder (MAH) system separating drug… - Clinical Trials in Human Medicines | European Medicines Agency (EMA)
All clinical trials included in marketing authorisation applications for human medicines in the EU/EEA must be conducted in accordance with Annex 1 of Directive 2001/83/EC. Trials in the EU/EEA must comply with EU… - Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC
This Implementing Regulation amends the pharmacovigilance performance rules in Regulation (EU) No 520/2012: it limits Pharmacovigilance System Master File deviation documentation to major or critical deviations,… - Commission Regulation (EC) No 1394/2007 of 13 November 2007 on Advanced Therapy Medicinal Products
This regulation requires manufacturers of advanced therapy medicinal products, including gene therapy, somatic cell therapy, and tissue-engineered products, to comply with the centralised authorisation procedure as… - Commission Regulation (EC) No 141/2000 of 16 December 1999 on Orphan Medicinal Products
This regulation requires that medicinal products intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in the European… - Commission Regulation (EU) No 1235/2010 of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004, Regulation (EC) No 1394/2007, Directive 2001/83/EC and Directive 2001/82/EC
This regulation requires marketing authorisation holders to submit periodic safety update reports (PSURs) to the European Medicines Agency, as outlined in Article 28a of Directive 2001/83/EC. It applies to all medicinal… - Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level
This Regulation establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (Article 1). The emergency framework is… - Current Good Manufacturing Practice for Finished Pharmaceuticals
This regulation, specifically 21 CFR 211.22, requires pharmaceutical manufacturers to establish and follow written procedures for quality control, and applies to all finished pharmaceuticals, as stated in 21 CFR 210.1. - Current Good Manufacturing Practice for Finished Pharmaceuticals
This regulation establishes the minimum requirements for methods, facilities, and controls used in the manufacturing, processing, packing, or holding of finished pharmaceuticals to ensure their safety, identity,… - Designating an Orphan Product: Drugs and Biological Products
This regulation establishes the process for sponsors to request orphan drug designation for drugs or biological products intended to prevent, diagnose, or treat rare diseases or conditions, as defined by the Orphan Drug… - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
This Directive establishes the legal framework for the authorization, manufacturing, labelling, advertising, and pharmacovigilance of medicinal products for human use within the European Union. It applies to all… - Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Establishes a simplified registration procedure for traditional herbal medicinal products (THMPs) in the EU based on at least 30 years of traditional use, including 15 years within the EU, under Article 16a of Directive… - Directive 2010/84/EU of the European Parliament and of the Council of 19 January 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
This directive establishes a robust pharmacovigilance system for medicinal products in the EU, mandating marketing authorization holders (MAHs) to monitor, report, and manage adverse drug reactions. Key obligations… - Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 on the prevention of the entry into the legal supply chain of falsified medicinal products for human use, amending Directive 2001/83/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council and repealing Directive 2004/27/EC
This directive mandates that all prescription medicines placed on the EU market must bear a unique identifier (UI) and tamper-evident feature (TEF), with verification at the point of dispensing. It applies to marketing… - Drug Supply Chain Security Act
The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers, wholesalers, and dispensers to implement a system for tracking and tracing certain prescription drugs, as outlined in Section 582 of the… - EMA PRIME Scheme - Priority Medicines (PRIority MEdicines): Early Dialogue for Unmet Medical Need Products, Dedicated Point of Contact, Free Scientific Advice, Proactive Support during Development, CHMP Appointment of Rapporteur and Rolling Review Option
The EMA PRIME scheme provides enhanced regulatory support to developers of medicines targeting unmet medical needs in the EU, based on preliminary clinical or non-clinical evidence of significant therapeutic potential.… - EU Clinical Trials Regulation 2014/536 - Authorisation and Conduct of Clinical Trials for Investigational Medicinal Products
Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) replaced Directive 2001/20/EC and establishes a harmonised procedure for clinical trial authorisation across the EU via the Clinical Trials Information… - EU Clinical Trials Regulation 536/2014 (CTR) - Investigational Medicinal Products and Trial Authorisation
Regulation (EU) No 536/2014 establishes a harmonised EU-wide authorisation procedure for clinical trials on investigational medicinal products via the Clinical Trials Information System (CTIS). Sponsors must obtain a… - EU Falsified Medicines Directive 2011/62/EU - Serialisation and Track-and-Trace Requirements
Directive 2011/62/EU and Commission Delegated Regulation (EU) 2016/161 require manufacturers, importers, and distributors of prescription medicines in the EU to implement a two-component safety feature system: a unique… - EU FMD Delegated Regulation 2016/161 - Safety Features and Unique Identifier for Medicinal Products
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC, applicable from 9 February 2019 in most EU/EEA Member States (with derogations for Greece and Italy until February… - EU GCP Directive 2005/28/EC and Clinical Trials Regulation 536/2014 - Good Clinical Practice in Clinical Trials
EU Good Clinical Practice (GCP) requirements established under Directive 2005/28/EC and now primarily governed by Clinical Trials Regulation (CTR) 536/2014 set the ethical and scientific quality standards for clinical… - EU GDP Good Distribution Practice 2013/C 343/01 - Medicinal Products Wholesale Distribution
EU GDP Guidelines 2013/C 343/01 establish Good Distribution Practice standards for wholesale distribution of medicinal products - covering temperature control, supply chain integrity, falsified medicine detection,… - EU GMP Annex 1 - Manufacture of Sterile Medicinal Products (2022)
This regulation requires manufacturers of sterile medicinal products to implement a contamination control strategy, as outlined in Article 17 of the EU GMP Guidelines, and to maintain a cleanroom environment that meets… - EU GMP Annex 3: Manufacture of Radiopharmaceuticals
EU GMP Annex 3 covers the manufacture of radiopharmaceuticals for human use, including positron emission tomography (PET) products, generator-derived products such as Tc-99m, and therapeutic radiopharmaceuticals. The… - EU Good Distribution Practice (GDP) Guidelines 2013 - European Commission Guideline 2013/C 343/01
The European Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), published in the Official Journal of the EU on 23 November 2013, set binding quality standards for… - EU Medicinal Products for Human Use Directive 2001/83/EC
Directive 2001/83/EC, as the core EU pharmaceutical legislation, requires a marketing authorisation (MA) for all medicinal products for human use before they may be placed on the EU market, establishes Good… - EU Paediatric Regulation 1901/2006 - Paediatric Investigation Plan and Waiver Requirements
Regulation (EC) No 1901/2006 requires all applications for new marketing authorisations (MAs) and extensions of indication to include a Paediatric Investigation Plan (PIP) agreed with EMA's Paediatric Committee (PDCO),… - EU Pharmaceutical Regulation (2022/0134) - Article 5: Marketing Authorisation Requirements
EU Pharmaceutical Regulation (proposed, replacing Directive 2001/83/EC) Article 5 maintains the core requirement that no medicinal product may be placed on the EU market without a marketing authorisation (MA) granted by… - FDA PDUFA VII Performance Goals and Procedures 2023-2027
The FDA PDUFA VII requires prescription drug manufacturers to meet specific performance goals and procedures for the review of new drug applications, as outlined in Section 735(1) of the Federal Food, Drug, and Cosmetic… - Federal Food, Drug, and Cosmetic Act 1938 - 21 USC 301
Section 301 of title 21 of the United States Code is the short title provision of the Federal Food, Drug, and Cosmetic Act (FDCA, Public Law 75-717, enacted 25 June 1938), the principal US statute governing the safety… - Food and Drug Regulations PART B Foods (continued) DIVISION 26 Food Irradiation
This regulation prohibits the sale of irradiated food in Canada unless specifically authorized under B.26.003(2) and listed in the Table, with compliance to specified radiation type, source, and absorbed dose limits. It… - Food and Drug Regulations Part C Division 5 - Clinical Trials
This regulation requires clinical trial sponsors to submit a Clinical Trial Application (CTA) to Health Canada, as outlined in Section C.05.005 of the Food and Drug Regulations, and to comply with the requirements for… - Food and Drugs Act, R.S.C., 1985, c. F-27 - Article 2: Interpretation and Application
This article establishes the legal definitions for key terms such as food, drug, cosmetic, and device, which determine the regulatory scope and obligations for products under the Food and Drugs Act. - Framework for Real-World Evidence Program Guidance 2018
The FDA Real-World Evidence Program Guidance 2018 requires sponsors to submit real-world evidence (RWE) studies that meet specific standards for data sources, study design, and fit-for-purpose, as outlined in Section II… - Ghana Food and Drugs Authority Act 1992 PNDC Law 305B Public Health Act 851 Drug Registration GMP Inspection Pharmacovigilance and African Medicines Agency Alignment
Ghana's Food and Drugs Authority (FDA Ghana) administered under the Public Health Act 851 of 2012 (which consolidates the Food and Drugs Law PNDC Law 305B of 1992) operates as the National Regulatory Authority for food… - Guidance for Industry: Breakthrough Therapies
The FDA Breakthrough Therapy Designation Guidance 2018 requires sponsors to submit a breakthrough therapy designation request, as outlined in Section 506(a) of the Federal Food, Drug, and Cosmetic Act, and provides… - Health Products (Therapeutic Products) Regulations 2016 (S 329/2016), made under the Health Products Act 2007 (Singapore)
Under the Health Products Act 2007 and the Health Products (Therapeutic Products) Regulations 2016 (S 329/2016), therapeutic products must be registered with the Health Sciences Authority (HSA) before supply in… - Health Products Act 2007 - Part 2 ADMINISTRATION
This article establishes the administrative framework for the Health Products Act, defining the Authority's responsibility and its powers to appoint enforcement officers, analysts, and advisory committees to oversee… - ICH E11(R1): Clinical Investigation of Medicinal Products in the Pediatric Population
ICH E11(R1) sets the framework for clinical investigation of medicinal products in the paediatric population (birth to 18 years). The R1 addendum (2017) added specific guidance on extrapolation, modelling and… - ICH E2E - Pharmacovigilance Planning: Safety Specification and Pharmacovigilance Plan (2004)
ICH E2E (Step 4, November 2004) requires a Safety Specification and Pharmacovigilance Plan to be submitted with marketing authorisation applications, defining important potential risks, missing safety information, and… - ICH E6(R3) Good Clinical Practice Revision 2023 - Risk-Proportionate Approaches, Decentralised Trials, Remote Monitoring and Data Integrity Standards
This regulation requires sponsors to implement risk-proportionate approaches to clinical trials, as outlined in Article 1.61, and to ensure data integrity, as specified in Article 1.62. It applies to all clinical trials… - ICH E8(R1) - General Considerations for Clinical Studies 2021: Quality, Risk-Based Approaches and Fit-for-Purpose Clinical Study Design
This regulation requires that clinical studies be designed to ensure the quality, safety, and efficacy of investigational products, as outlined in Article 1 of the ICH E8(R1) guideline, and applies to all clinical… - ICH E9(R1) - Addendum on Estimands and Sensitivity Analysis in Clinical Trials: Estimand Framework, Intercurrent Events and Missing Data Strategies
This regulation requires sponsors of clinical trials to identify and justify the estimand of interest, as stated in Section 1.1, and to conduct sensitivity analyses to assess the robustness of the results, as outlined… - ICH M12 - Drug Interaction Studies: In Vitro and In Vivo Assessment, Clinical Pharmacokinetic Studies and Product Labelling Recommendations
This regulation requires sponsors to conduct in vitro and in vivo drug interaction studies, as outlined in Article 3, and to include the results in the product labeling, as stated in Article 7, to ensure the safe and… - ICH M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ICH M3(R2) sets the framework for nonclinical safety studies required to support human clinical trials and marketing authorisation. The guideline addresses general toxicology, safety pharmacology, genotoxicity,… - ICH M4 - Common Technical Document (CTD): 5-Module Structure for Global Regulatory Submissions (2002)
ICH M4 (Step 4, 2001-2004) defines the 5-module Common Technical Document format - the universal standard for marketing authorisation applications in EU, US, Japan, Canada, and all ICH Member jurisdictions - covering… - ICH Q10 Pharmaceutical Quality System - Design, Development, Manufacturing and Discontinuation: Quality System Elements and Enablers
This regulation requires pharmaceutical manufacturers to establish a quality system that includes design, development, manufacturing, and discontinuation, as outlined in Clause 1.1. It applies to all pharmaceutical… - ICH Q10 Pharmaceutical Quality System - Product Lifecycle Management
ICH Q10 describes a comprehensive pharmaceutical quality system (PQS) model covering the entire product lifecycle from development through discontinuation. It builds on Good Manufacturing Practice (GMP) requirements and… - ICH Q11: Development and Manufacture of Drug Substances: Design Space, Control Strategy and Manufacturing Process Development
This regulation requires drug manufacturers to establish a control strategy that includes design space, and to develop a manufacturing process that meets the requirements of ICH Q11, Article 1. According to Article 2,… - ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Established Conditions and Post-Approval Changes
ICH Q12 requires pharmaceutical manufacturers to establish and maintain a pharmaceutical quality system, as outlined in Article 1 of the guideline, and to implement post-approval changes in accordance with Article 3. - ICH Q13 - Continuous Manufacturing of Drug Substances and Drug Products: Regulatory Expectations, Control Strategy and Real-Time Release Testing
ICH Q13 requires pharmaceutical manufacturers to implement a control strategy for continuous manufacturing, as outlined in Section 3, and to conduct real-time release testing, as specified in Section 5. - ICH Q14 - Analytical Procedure Development and Lifecycle Management (2023)
ICH Q14 (Step 4, November 2023) establishes a science- and risk-based framework for analytical procedure development, defining Analytical Target Profiles (ATP) and Analytical Procedure Performance Indicators (APPIs) to… - ICH Q2(R2) - Validation of Analytical Procedures: Methodology and Acceptance Criteria (2022)
ICH Q2(R2) (Step 4, November 2022) updates the 1994 Q2(R1) validation guideline by integrating life sciences analytical techniques (biological assays, spectroscopic methods, multivariate analysis), defining validation… - ICH Q3A(R2): Impurities in New Drug Substances
ICH Q3A(R2) sets reporting, identification, and qualification thresholds for organic impurities in new drug substances based on maximum daily dose. The guideline applies to chemically synthesised new drug substances and… - ICH Q3B(R2): Impurities in New Drug Products
ICH Q3B(R2) sets thresholds for degradation products in new drug products based on maximum daily dose. The guideline addresses impurities arising during manufacture, storage, or stability testing of the drug product but… - ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH Q4B provides a framework for evaluating Ph. Eur., USP, and JP pharmacopoeial general chapters to determine interchangeability across ICH regions, reducing duplicative testing. Annex 1 through Annex 16 cover specific… - ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
ICH Q5E sets the framework for demonstrating that a biotech or biological product remains the same when its manufacturing process changes. The guideline applies to facility moves, cell line changes, fermentation… - ICH Q9(R1) Quality Risk Management
ICH Q9(R1) requires pharmaceutical manufacturers to implement a quality risk management system, as outlined in Section 1.1, to ensure the quality of their products. This applies to all pharmaceutical companies, as… - ICH Q9(R1) Quality Risk Management - Risk Assessment, Risk Control and Risk Communication in Pharmaceutical Manufacturing
ICH Q9(R1) Quality Risk Management is the revised version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9 guideline, reached Step 4 of the ICH process… - ICH S2(R1): Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
ICH S2(R1) defines the standard battery of genotoxicity tests for pharmaceuticals intended for human use, supporting first-in-human trials and marketing applications. The R1 revision rationalised the testing strategy… - ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals: Timing of Studies, General Toxicology, Genotoxicity and Reproductive Toxicology
This regulation requires that nonclinical studies for anticancer pharmaceuticals be conducted in accordance with ICH S9, specifically Section 3, to ensure the safety and efficacy of these products. It applies to… - India Drugs and Cosmetics Act 1940 - CDSCO Drug Approval, Schedule M GMP and Clinical Trial Regulation
India's Drugs and Cosmetics Act 1940 (D&C Act) and the New Drugs and Clinical Trials Rules 2019 (NDCT Rules), administered by the Central Drugs Standard Control Organisation (CDSCO) under the Drug Controller General of… - Indonesia BPOM Drug Registration Regulations Badan Pengawas Obat dan Makanan Marketing Authorisation GMP Pharmacovigilance and Halal Certification Framework
The Indonesia Badan Pengawas Obat dan Makanan (BPOM) National Agency of Drug and Food Control administered under Presidential Regulation No. 80 of 2017 (as amended) establishes the comprehensive pharmaceutical… - Investigational New Drug Application
This regulation establishes the requirements for submitting an Investigational New Drug (IND) application to the FDA, including content, safety reporting, protocol amendments, and annual reports, and applies to sponsors… - Investigational New Drug Application: IND Content, Phases of Investigation, Safety Reporting and Annual Reports
This regulation requires sponsors of investigational new drugs to submit an Investigational New Drug Application (IND) to the FDA, as outlined in 21 CFR 312.20-312.33, and to conduct investigations in accordance with 21… - ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 13485:2016 requires medical device manufacturers to establish a quality management system that meets regulatory requirements, as outlined in Clause 4.1, and to implement risk management processes, as specified in… - ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness by Particle Concentration
This regulation requires cleanroom operators to classify their air cleanliness by particle concentration, as specified in Clause 5, and applies to all cleanroom facilities in the pharmaceutical and life sciences… - Japan Pharmaceutical and Medical Device Act (PMDA) - Drug Approval: Clinical Trial Notification, PMDA Consultation, Approval Review, Manufacturing Site Registration, GMP Conformity Assessment and Post-Marketing Vigilance
This regulation governs the approval pathway for pharmaceuticals in Japan, requiring clinical trial notifications, PMDA consultation, manufacturing site registration, GMP conformity assessment, and post-marketing safety… - Japan Pharmaceutical and Medical Devices Act 2014
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, substantially amended in 2014 as the Pharmaceutical and Medical Devices Act and further… - Medicinal Products Act (Gesetz ueber den Verkehr mit Arzneimitteln - Arzneimittelgesetz - AMG)
This Act governs trade in medicinal products to guarantee their safety, quality and efficacy (Section 1). It defines medicinal products, substances and related terms (Sections 2 to 4), prohibits unsafe and falsified… - Mexico Ley General de Salud General Health Law COFEPRIS Drug Registration Manufacturing Authorisation Health Surveillance and Pharmacovigilance Framework
The Mexican Ley General de Salud (General Health Law) of 7 February 1984 as amended establishes the comprehensive framework for health regulation including pharmaceuticals administered by the Comisión Federal para la… - New Drug Applications: Chemistry-Manufacturing-Controls, Clinical Data Requirements, Labelling and Post-Marketing Commitments
This regulation requires new drug applicants to submit a New Drug Application (NDA) that includes chemistry, manufacturing, and controls information, as well as clinical data, labeling, and post-marketing commitments,… - OECD Revised Principles of Good Laboratory Practice (1997)
The OECD Revised Principles of Good Laboratory Practice (1997) require test facilities to establish a quality assurance programme, as outlined in Principle 2, and to designate a study director, as stated in Principle 8.… - Orphan Drug Act of 1983, Section 526 - Designation of Orphan Drugs
The Orphan Drug Act of 1983, Section 526, requires the FDA to designate a drug as an orphan drug if it is intended for the treatment of a rare disease or condition, defined as one that affects fewer than 200,000 people… - Patented Medicine Prices Review Board Guidelines 2021
The Patented Medicine Prices Review Board (PMPRB) Guidelines 2021 require that the price of a patented medicine in Canada not exceed the median price of the same medicine in seven comparator countries, as per Section 4… - Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect user fees from persons submitting certain human drug applications for review or named as sponsors in approved applications. Application fees are… - Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004
This regulation establishes a centralized authorization pathway and specific safety, quality, and efficacy requirements for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and… - Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004
This regulation establishes a centralized authorization pathway for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and tissue-engineered products, within the EU. It mandates… - Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
This regulation mandates that pharmaceutical developers submit a Paediatric Investigation Plan (PIP) to the European Medicines Agency's Paediatric Committee (PDCO) before initiating clinical trials for new medicines,… - Regulation (EC) No 1901/2006 of the European Parliament and of the Council on Medicinal Products for Paediatric Use
This regulation requires pharmaceutical companies to submit a Paediatric Investigation Plan (PIP) for new medicinal products, as outlined in Article 7 of the regulation, and provides rewards for compliance, including a… - Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
This regulation establishes the centralised procedure for authorising medicinal products in the European Union, mandating its use for high-technology products (e.g., biotech-derived), orphan medicinal products, and new… - Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
The EU Medical Devices Regulation (MDR) 2017/745 establishes a comprehensive framework for the safety and performance of medical devices in the EU, requiring manufacturers to classify devices (Annex VIII), generate… - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
The EU In Vitro Diagnostic Regulation 2017/746 requires manufacturers of in vitro diagnostic medical devices to comply with the requirements outlined in Article 17, including the conduct of performance studies and the… - Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
This Regulation reinforces the role of the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Article 1). It establishes the Executive Steering Group on Shortages… - Resolution RDC 204, 2017 - Good Manufacturing Practices for Pharmaceutical Inputs: Active Ingredients, Excipients and Primary Packaging
This regulation requires pharmaceutical manufacturers to comply with Good Manufacturing Practices (GMP) as outlined in Article 5, and applies to all establishments that manufacture, fractionate, assemble, package, and… - Saudi Arabia SFDA Pharmaceutical Regulations Saudi Food and Drug Authority Drug Registration Pricing Manufacturing Authorisation Vision 2030 Localisation Framework
The Kingdom of Saudi Arabia Saudi Food and Drug Authority (SFDA) administers the comprehensive pharmaceutical regulation framework under the SFDA Law promulgated by Royal Decree No. M/6 of 1428H establishing SFDA as an… - South Korea MFDS Pharmaceutical Affairs Act 2023 - Drug Approval, GMP Inspection and Pharmacovigilance
South Korea's Pharmaceutical Affairs Act (PAA, Act No. 901, 29 December 1953, consolidated to 2023) administered by the Ministry of Food and Drug Safety (MFDS - Sikhum-uiyakhum) regulates drug marketing approval (품목허가 -… - The Human Medicines Regulations 2012
The UK Human Medicines Regulations 2012 (SI 2012/1916) require marketing authorisation holders to comply with pharmacovigilance requirements, as outlined in Regulation 187. This regulation applies to all marketing… - The Medicines for Human Use (Clinical Trials) Regulations 2004
The UK MHRA Good Clinical Practice Regulations 2004 require sponsors and investigators to comply with the principles of Good Clinical Practice, as outlined in Regulation 3, and to obtain authorization for clinical… - Therapeutic Goods Act 1989
The Therapeutic Goods Act 1989 requires that all therapeutic goods be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia, as per Section 9 of the Act. - UK Human Medicines Regulations 2012
The Human Medicines Regulations 2012 (SI 2012/1916) is the primary UK pharmaceutical legislation governing the authorisation, manufacture, importation, distribution, and advertising of human medicines, with the MHRA as… - United States Controlled Substances Act (Title 21 USC Chapter 13): Congressional Findings, Schedules of Controlled Substances, Registration of Manufacturers and Distributors, Prescription Requirements, and Penalties
The Controlled Substances Act, codified at Title 21 of the United States Code, Chapter 13, is the principal federal statute governing the manufacture, distribution, dispensing, importation, and exportation of controlled… - US 21 CFR Part 1308: Schedules of Controlled Substances (DEA)
US 21 CFR Part 1308 implements the Controlled Substances Act (CSA) Schedules I through V by listing controlled substances by chemical identity and scheduling status. Schedule I substances have no currently accepted… - US 21 CFR Part 207: Drug Establishment Registration and Drug Listing
US 21 CFR Part 207 requires owners and operators of all drug establishments to register with the FDA and submit information about each drug they manufacture, repack, relabel, or salvage. The regulation covers initial… - US 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing Processing Packing or Holding of Drugs - General
US 21 CFR Part 210 establishes the general provisions and definitions for current good manufacturing practice (cGMP) regulations under the Federal Food Drug and Cosmetic Act. The regulation defines key terms (active… - US 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
US 21 CFR Part 211 prescribes the cGMP requirements for finished pharmaceuticals manufactured, processed, packed, or held in the US. Subparts cover organization and personnel, buildings and facilities, equipment,… - US 21 CFR Part 312: Investigational New Drug Application
US 21 CFR Part 312 sets requirements for the Investigational New Drug (IND) application process governing clinical investigation of drugs and biologics in humans. The regulation covers IND content (Forms FDA 1571 and… - US 21 CFR Part 314: Applications for FDA Approval to Market a New Drug
US 21 CFR Part 314 sets requirements for New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions to FDA for marketing approval. The regulation covers NDA content (clinical and nonclinical… - US 21 CFR Part 320: Bioavailability and Bioequivalence Requirements
US 21 CFR Part 320 sets the requirements for demonstrating bioavailability (BA) and bioequivalence (BE) for drug products submitted under NDA, ANDA, INDs, and supplements. The regulation defines BA as the rate and… - US 21 CFR Part 50: Protection of Human Subjects
US 21 CFR Part 50 sets requirements for informed consent of human subjects in FDA-regulated clinical investigations of drugs, biologics, devices, and other products. The regulation covers general requirements for… - US 21 CFR Part 56: Institutional Review Boards
US 21 CFR Part 56 sets requirements for IRB membership, functions, operations, review of research, recordkeeping, and IRB-related submissions and approvals for FDA-regulated clinical investigations. The regulation… - US 21 CFR Part 600: Biological Products: General
US 21 CFR Part 600 sets out general requirements for the regulation of biological products including establishment standards, inspection authority of FDA, reporting of adverse experiences and biological product… - US Controlled Substances Act (21 USC ch 13): Scheduling, Registration and Trafficking Penalties
The Controlled Substances Act (21 U.S.C. ch. 13) is the federal statute regulating the manufacture, distribution, dispensing and possession of controlled substances, administered by the Drug Enforcement Administration… - US DEA 21 CFR Parts 1301-1308 - Controlled Substances Registration and Manufacturing Requirements
The US Drug Enforcement Administration (DEA) regulations at 21 CFR Parts 1301-1308 implement the Controlled Substances Act (CSA), requiring registration for all manufacturers, distributors, dispensers, and researchers… - US FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures in FDA-Regulated Industries
US FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures for FDA-regulated… - US FDA 21 CFR Part 312 - Investigational New Drug (IND) Application Requirements
FDA regulations at 21 CFR Part 312 govern the Investigational New Drug (IND) application process required before conducting clinical studies of unapproved drugs or approved drugs for new indications in the US. Sponsors… - US FDA Amendments Act 2007 FDAAA Public Law 110-85 REMS Risk Evaluation and Mitigation Strategies Post-Market Safety Authority Clinical Trial Registration and User Fees
The Food and Drug Administration Amendments Act of 2007 Public Law 110-85 enacted on 27 September 2007 substantially expands FDA authority to ensure post-market drug safety organised in nine titles covering Title I… - US FDA Combination Products - 21 CFR Part 3: Device/Drug/Biologic Combination Classification, Primary Mode of Action (PMOA) Determination, Intercenter Agreement (ICA) Assignment, Integrated Review Process, NDA/PMA/BLA Pathway Selection and Post-Market Surveillance Responsibilities
This regulation governs the classification, jurisdictional assignment, and regulatory pathway for combination products consisting of drugs, devices, and/or biological products under 21 CFR Part 3. It requires sponsors… - US FDA Real-World Evidence Programme 2018 - RWE Framework for Drug and Biological Products: Real-World Data Sources, Study Designs, Data Standards, Regulatory Submissions and Programme Guidance
This regulation outlines the FDA's framework for using real-world data (RWD) and real-world evidence (RWE) to support regulatory decisions for drugs and biological products, including approval of new indications under… - US Federal Food, Drug, and Cosmetic Act (21 USC ch 9): Prohibited Acts, Adulteration, New Drug Approval and Penalties
The Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 U.S.C. ch. 9) is the principal US statute regulating the safety and labeling of food, drugs, medical devices, cosmetics and tobacco, administered by the Food and… - US Food and Drug Administration Modernization Act of 1997 (Public Law 105-115) - FDA Statutory Reform
The Food and Drug Administration Modernization Act of 1997 reauthorised the Prescription Drug User Fee Act, created an accelerated approval pathway for drugs treating serious or life-threatening conditions, codified the… - US Orphan Drug Act (21 USC ch 9): Incentives for Rare Disease Drugs
The Orphan Drug Act, codified within the Federal Food, Drug, and Cosmetic Act (21 U.S.C. ch. 9, sections 360aa to 360ff), creates incentives to develop drugs for rare diseases or conditions, administered by the Food and… - WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles
The WHO Good Manufacturing Practices require pharmaceutical manufacturers to establish a quality management system, as outlined in Section 1.1, and to ensure that personnel are trained and qualified, as stated in…
⚠ Important: Human Verification Required
Bidda compliance nodes are reference intelligence, not legal advice. Every node must be reviewed by a qualified compliance professional or legal counsel before implementation in any enterprise workflow, regulated system, or compliance programme. See bidda.com/disclaimer for full terms.