Biotech & Genomics — 111 Nodes
- 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
Part 58 mandates that any nonclinical laboratory study supporting FDA product applications must follow Good Laboratory Practice, including qualified personnel (§ 58.29), a designated study director (§ 58.33), a quality… - 35 U.S. Code Chapter 18 Part II - Patent Rights in Inventions Made with Federal Assistance
This regulation governs the ownership, reporting, and licensing of inventions made with federal funding, allowing contractors (e.g., universities) to elect title to inventions under § 202, subject to government rights… - 40 CFR Part 725 - Reporting Requirements for Microbial Products of Biotechnology (TSCA)
EPA 40 CFR Part 725 sets the TSCA reporting requirements for microbial products of biotechnology, requiring submitters to identify intergeneric microorganisms, file a Microbial Commercial Activity Notice (MCAN) before… - 7 CFR Part 340 - Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests (USDA APHIS)
7 CFR Part 340 prohibits any person from introducing a regulated article (an organism or product altered or produced through genetic engineering that is or may be a plant pest) unless APHIS is notified or the… - 7 USC § 2131 - Animal Welfare Act (Congressional Statement of Policy)
7 USC § 2131 (Animal Welfare Act of 1966, originally enacted as Pub. L. 89-544 / Laboratory Animal Welfare Act, amended substantially by Pub. L. 91-579 (1970), Pub. L. 94-279 (1976), Pub. L. 99-198 (1985 Food Security… - Assisted Human Reproduction Act
The Assisted Human Reproduction Act prohibits specific reproductive technologies and activities involving human cloning, chimeras, hybrids, and genetic modifications that can be transmitted to descendants. It applies to… - Australia NHMRC Biobanks Information Paper and National Statement on Ethical Conduct in Human Research
The National Health and Medical Research Council (NHMRC) Biobanks Information Paper (2010) and the National Statement on Ethical Conduct in Human Research (issued jointly with the Australian Research Council and… - Biologics License Applications (BLA) Process (CBER) - Request for Permission to Introduce a Biologic Product into Interstate Commerce under 21 CFR 601.2
This regulation governs the submission and approval of Biologics License Applications (BLAs) for introducing biologic products into interstate commerce, as required under 21 CFR 601.2. It applies to any legal person or… - Biosecurity Law of the People's Republic of China (2021)
The Biosecurity Law of the People's Republic of China (2021) maintains national security and safeguards public health, biological resources and the ecological environment (Article 1). Article 34 prohibits biotechnology… - Brazil Biosafety Law 11105/2005 - CTNBio GMO and Human Embryo Research Regulation
Brazil's National Biosafety Law (Law 11105/2005) establishes CTNBio (National Technical Biosafety Commission) as the sole authority for risk assessment and commercial release approvals of genetically modified organisms… - Brazil Fiocruz Biodiversity Biobank and Genomic Resources Governance under Law 13,123/2015 (CGen)
Brazil's principal biobank and genomic resources governance framework is established by Law 13,123/2015 (Lei da Biodiversidade), which regulates access to Brazilian genetic heritage and traditional knowledge associated… - Canada CEPA 1999 New Substances Notification - Biotechnology Living Organisms, ECCC Dual Assessment and Risk Management
The Canadian Environmental Protection Act 1999 (CEPA 1999, S.C. 1999, c. 33) Part 6 (New Substances) requires notification to the Government of Canada before manufacturing or importing any substance (including living… - Canada TCPS 2 (2018) - Tri-Council Policy Statement on Research Ethics
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2018 edition) is the joint policy of Canada's three federal research agencies (CIHR, NSERC, SSHRC). It mandates Research Ethics… - Cartagena Protocol on Biosafety 2000 - Living Modified Organisms (LMO) Transboundary Movement, Risk Assessment and Advance Informed Agreement Procedure
The Cartagena Protocol on Biosafety regulates the transboundary movement of living modified organisms (LMOs) to protect biological diversity, requiring advance informed agreement (AIA) procedures under Article 7 for… - CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) - 6th Edition (2025)
Laboratory operators handling potentially hazardous biological agents and toxins should run a comprehensive, continually-updated biosafety risk assessment under Section II of BMBL, select the appropriate Biosafety Level… - China Regulations on Management of Human Genetic Resources State Council Order No. 717 2019 Collection Preservation International Use and Cross-Border Sharing Approval Regime
The People's Republic of China Regulations on the Management of Human Genetic Resources promulgated by State Council Order No. 717 effective 1 July 2019 administered by the Ministry of Science and Technology Human… - China Regulations on the Management of Human Genetic Resources (State Council Order No. 717, 2019)
China's Regulations on the Management of Human Genetic Resources were promulgated by the State Council as Order No. 717 on 28 May 2019 and entered into force on 1 July 2019. The Regulations are administered by the Human… - Code of Federal Regulations, Title 45, Part 46 - Protection of Human Subjects
The Common Rule (45 CFR Part 46) establishes federal policy for the protection of human subjects in research, requiring Institutional Review Board (IRB) review, informed consent, and additional safeguards for vulnerable… - Convention on Biological Diversity (CBD) 1992 - Sovereign Rights over Genetic Resources, Access and Benefit-Sharing (ABS) and Conservation Obligations
The Convention on Biological Diversity (CBD) requires sovereign states to conserve biological diversity, ensure sustainable use of its components, and promote fair and equitable sharing of benefits arising from genetic… - Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction
The BWC prohibits state parties from developing, producing, stockpiling, acquiring, or retaining biological agents or toxins of types and in quantities that have no justification for peaceful purposes, under Article I.… - Coordinated Framework for the Regulation of Biotechnology
Establishes the jurisdictional roles of the FDA, EPA, and USDA in regulating genetically modified organisms (GMOs) based on product type and intended use, pursuant to existing statutory authorities including the Federal… - Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
This directive establishes a harmonized framework for the deliberate release of genetically modified organisms (GMOs) into the environment for research, field trials, or market authorization within the EU. It mandates… - Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms - Article 15
This article outlines the standard procedure for competent authorities and the Commission to review, object to, or grant consent for placing Genetically Modified Organisms (GMOs) on the market, including specific… - Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms - Article 20: Monitoring and handling of new information
Notifiers must ensure post-market monitoring and reporting for GMOs are conducted according to the conditions specified in the consent, submitting reports to the Commission and Member State competent authorities. - Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms - Article 6
This article establishes the procedural requirements for Member States and the Commission regarding the notification, summary forwarding, observation period, and final decision reporting for the experimental release of… - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms - Article 13: Notification procedure
Organizations must submit a detailed notification to the competent authority of the first Member State where a genetically modified organism (GMO) product is to be placed on the market. - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms - Article 2 Definitions
This article requires organizations to classify their biological entities, genetic modification techniques, and market activities according to the specific legal definitions provided for 'GMO', 'deliberate release', and… - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms - Article 23: Safeguard clause
This article outlines the safeguard clause allowing a Member State to provisionally restrict or prohibit a consented GMO product if new information indicates a risk to human health or the environment, and details the… - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms - Article 26: Labelling of GMOs referred to in Article 2(4), second subparagraph
Organizations must ensure that GMOs intended for specific operations are clearly labelled with the words 'This product contains genetically modified organisms' on a label or in an accompanying document, in line with… - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms - Article 4: General obligations
Organizations must conduct a comprehensive environmental risk assessment before notifying authorities for the deliberate release or marketing of GMOs, with specific requirements for phasing out certain antibiotic… - Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
This Directive establishes binding quality and safety standards for all stages of the human tissues and cells lifecycle across EU Member States, including donation, procurement, testing, processing, storage, and… - Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast)
This Directive requires all EU member states to ensure that genetically modified microorganisms (GMMs) are used only under contained conditions that prevent adverse effects on human health and the environment. It… - Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance)
This Directive establishes a framework for the safe contained use of genetically modified micro-organisms (GMMs) in the EU, requiring risk classification, containment measures, and notification to competent authorities… - Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions
This directive establishes the conditions under which biotechnological inventions are patentable in the European Union, including isolated gene sequences, provided they meet novelty, inventive step, and industrial… - EBRC Engineering Biology Safety Guidelines 2023 - Biosafety by Design: Synthetic Biology Containment Strategies, Genetic Use Restriction, Horizontal Gene Transfer Risk Assessment, Dual-Use Research of Concern (DURC) Review and Institutional Biosafety Committee Obligations
This guidance establishes biosafety and biosecurity best practices for engineering biology research, focusing on synthetic biology containment, genetic use restriction technologies (GURT), horizontal gene transfer risk… - EMA Good Pharmacovigilance Practices Module V - Risk Management Systems 2014
EMA Good Pharmacovigilance Practices (GVP) Module V (Revision 2, 2017) requires marketing authorisation holders of EU medicinal products to maintain a Risk Management System throughout the product lifecycle, submitting… - EMA Reflection Paper on CRISPR Genome Editing - Quality Considerations, Off-Target Analysis, Manufacturing Controls, Non-Clinical Studies and Regulatory Classification for Gene-Edited Products
This reflection paper provides scientific considerations for the development of CRISPR-based gene-edited medicinal products, focusing on quality, off-target analysis, manufacturing controls, and non-clinical evaluation.… - EU Advanced Therapy Medicinal Products Regulation 1394/2007 - Cell, Gene, and Tissue Therapies
Regulation (EC) No 1394/2007 establishes the regulatory framework for Advanced Therapy Medicinal Products (ATMPs) in the EU, covering gene therapy, somatic cell therapy, tissue-engineered products, and combined ATMPs.… - EU Advanced Therapy Medicinal Products Regulation 1394/2007 - Gene Therapy, Cell Therapy, and Tissue Engineering Authorisation
Regulation (EC) No 1394/2007 of 13 November 2007 establishes the EU regulatory framework for advanced therapy medicinal products (ATMPs). ATMPs are defined in Article 2 as gene therapy medicinal products (GTMPs),… - EU Clinical Trials Regulation 2014/536 - Clinical Trial Authorisation, CTIS, and Informed Consent
Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use replaced Directive 2001/20/EC and became applicable from 31 January 2022. The Regulation… - EU European Health Data Space Regulation (Regulation (EU) 2025/327)
Regulation (EU) 2025/327 of the European Parliament and of the Council establishes the European Health Data Space (EHDS). It was published in the Official Journal of the European Union on 5 March 2025 and entered into… - EU GMO Deliberate Release Directive 2001/18/EC - Environmental Risk Assessment and Market Authorisation
Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms (GMOs) establishes the regulatory framework for the controlled and… - EU GMO Regulation 1829/2003 - Authorisation, Labelling & Traceability of GM Food and Feed
Regulation 1829/2003 establishes a centralised EU authorisation procedure for genetically modified food and feed, mandatory labelling above 0.9% GMO threshold, and a 10-year renewable authorisation with ongoing… - EU Regulation 726/2004 - EMA Centralised Procedure for Marketing Authorisation of Medicinal Products
Regulation (EC) No 726/2004 establishes the centralised procedure for European Medicines Agency (EMA) marketing authorisation (MA) of medicines for human and veterinary use. Centralised MAs grant simultaneous marketing… - FDA Process Validation Guidance - Lifecycle Approach 2011
FDA's 2011 Process Validation guidance establishes a lifecycle approach in three stages - process design, process qualification, and continued process verification - requiring manufacturers to collect and evaluate data… - GA4GH Framework for Responsible Sharing of Genomic and Health-Related Data (Version 2)
The Global Alliance for Genomics and Health (GA4GH) is an international, non-profit standards body that produces technical and policy standards for the responsible sharing of genomic and health-related data. The GA4GH… - Gene Technology Act 2000 - Regulation of Dealings with GMOs, Licensing, and Environmental Risk Management
The Gene Technology Act 2000 establishes a national framework for regulating dealings with genetically modified organisms (GMOs), requiring all such dealings to be licensed unless exempted, with strict liability for… - Gene Technology Act 2000 (Cth)
The Act requires any person dealing with a genetically modified organism (GMO) to obtain a licence (Section 32) and to comply with licence conditions, including preparation of a risk assessment and risk management plan… - Genetic Information Nondiscrimination Act of 2008 - Prohibiting Employment Discrimination on the Basis of Genetic Information
The Genetic Information Nondiscrimination Act (GINA) of 2008 prohibits employers with 15 or more employees from using genetic information in employment decisions, including hiring, firing, and promotions, and restricts… - Guidance for Human Gene Therapy Investigational New Drug Applications (INDs): CMC, Preclinical, and Clinical Considerations
This FDA guidance outlines chemistry, manufacturing, and controls (CMC), preclinical, and clinical requirements for gene therapy INDs under 21 CFR Part 312. It applies to sponsors developing human gene therapy products… - Guideline on Quality, Non-Clinical and Clinical Requirements for Marketing Authorisation of Advanced Therapy Medicinal Products
This guideline sets out the quality, non-clinical, and clinical requirements for marketing authorisation of advanced therapy medicinal products (ATMPs) in the European Union, including gene therapy, somatic cell… - Human Tissue Act 2004
The Human Tissue Act 2004 requires that any removal, storage or use of human tissue for scheduled purposes-including biobanking-must be performed only with appropriate consent (Section 3 for adults, Section 2 for… - Human Tissue Act 2004 - Consent Requirements, Licensed Activities for Human Biological Material and Human Tissue Authority (HTA) Oversight
The Human Tissue Act 2004 establishes a legal framework for the removal, storage, and use of human tissue in England, Wales, and Northern Ireland, requiring appropriate consent for scheduled purposes under Section 1 and… - ICH Q5A(R2) Viral Safety Evaluation of Biotechnology-Derived Products 2024 - Viral Clearance Studies, Testing Strategy and Risk Assessment Framework
This regulation requires manufacturers of biotechnology-derived products to conduct viral clearance studies using validated methods to demonstrate removal or inactivation of potential viral contaminants, particularly… - ICH Q5D - Derivation and Characterisation of Cell Substrates for Biological Products
ICH Q5D (adopted by ICH Step 4 in November 1997, implemented globally in 1998) establishes the international standard for derivation, characterisation, and ongoing management of cell substrates (Master Cell Banks and… - ICH S10: Photosafety Evaluation of Pharmaceuticals
ICH S10 provides a tiered approach to photosafety assessment for pharmaceuticals: starting with photochemical characterisation (molar absorption coefficient, quantum yield, photodegradation), proceeding to the 3T3 NRU… - ICH S12 - Nonclinical Biodistribution Considerations for Gene Therapy Products (2023)
ICH Guideline S12 (finalized September 2023, Step 4) establishes the nonclinical biodistribution study design principles for gene therapy products, specifying when biodistribution studies are required, acceptable animal… - ICH S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals
ICH S5(R3) mandates species-specific DART study designs for all new human pharmaceuticals, requiring fertility, embryo-fetal development, and pre/postnatal development studies, with extended one-generation reproductive… - ICH S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH S6(R1) establishes the framework for preclinical safety assessment of biologics including monoclonal antibodies, recombinant proteins, and gene therapies, requiring pharmacologically relevant species selection,… - ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals
ICH S7A mandates a core safety pharmacology battery assessing cardiovascular (hERG, telemetry), CNS (Irwin/FOB), and respiratory function for all new pharmaceutical candidates before first human dosing, with follow-up… - ICH S8 - Immunotoxicity Studies for Human Pharmaceuticals: Non-Clinical Safety Assessment Guideline
ICH S8 (November 2005, adopted by EMA, FDA, PMDA) provides guidance for non-clinical evaluation of immunotoxic potential of new human pharmaceuticals using a tiered testing approach; the standard battery of toxicology… - India Biological Diversity Act 2002 - Access to Biological Resources and Benefit Sharing
India's Biological Diversity Act 2002 (Act 18 of 2003) implements the Convention on Biological Diversity's access and benefit-sharing (ABS) framework: foreign nationals and companies require prior National Biodiversity… - ISBER Best Practices for Repositories: Collection, Storage, Retrieval, Release and Disposal of Biospecimens, 4th Edition (2018)
This standard establishes comprehensive requirements for the ethical, safe, and scientifically valid management of human and non-human biospecimens throughout their lifecycle, including collection, processing, storage,… - ISO 20387:2018 Biotechnology - Biobanking - General Requirements for Biobanking
ISO 20387:2018 Biotechnology - Biobanking - General Requirements for Biobanking is the international standard specifying the management and technical requirements for biobanks to enable them to demonstrate competence in… - ISSCR Guidelines for Stem Cell Research and Clinical Translation (2021)
The International Society for Stem Cell Research (ISSCR) 2021 Guidelines for Stem Cell Research and Clinical Translation represent the international consensus framework governing embryonic stem cell research, human… - Japan Cartagena Act 2003 - Law on Conservation of Biological Diversity through LMO Regulation
Japan's Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Act No. 97 of 2003, amended 2022) implements the Cartagena Protocol domestically,… - Kenya Biosafety Act No. 2 of 2009
The Kenya Biosafety Act No. 2 of 2009 regulates activities involving genetically modified organisms and establishes the National Biosafety Authority under Section 5. Sections 18 to 21 require written approval from the… - Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity
The Nagoya Protocol requires users of genetic resources to obtain prior informed consent (PIC) from provider countries and establish mutually agreed terms (MAT) for benefit-sharing. It applies to all activities… - NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2019 Revision)
These guidelines establish biosafety levels, containment practices, and Institutional Biosafety Committee (IBC) review requirements for all research involving recombinant or synthetic nucleic acid molecules conducted at… - NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2019)
Institutions conducting recombinant or synthetic nucleic acid research in the U.S. must register with the NIH Office of Science Policy and establish an Institutional Biosafety Committee (IBC) to review and approve all… - OECD Guidelines on Human Biobanks and Genetic Research Databases 2009 - Consent, Data Governance, Sample Access and Benefit-Sharing Principles
These guidelines establish international standards for the governance of human biobanks and genetic research databases, requiring informed consent, data protection, equitable access to samples, and benefit-sharing. Key… - OECD Guidelines on Safety Considerations for Biotechnology 2000 - Contained Use Risk Assessment, Scale-Up Considerations, Worker Health Monitoring and Environmental Release Controls
These OECD Guidelines establish a risk-based framework for the safe handling of genetically modified organisms (GMOs) during contained use, scale-up, and environmental release, with specific requirements for risk… - Possession, Use and Transfer of Biological Select Agents and Toxins (42 CFR Part 73 and 9 CFR Part 121)
This regulation establishes requirements for entities possessing, using, or transferring biological select agents and toxins (BSAT) that have the potential to pose a severe threat to public, animal, or plant health. It… - 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 procedure for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and tissue-engineered products, within the European Union.… - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products
This regulation establishes the framework for the designation of orphan medicinal products in the EU for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions affecting no… - Regulation (EC) No 1829/2003 - Authorisation and Labelling of Genetically Modified Food and Feed
Regulation (EC) No 1829/2003 requires that all genetically modified food and feed placed on the EU market receive a centralised authorisation from the European Commission, preceded by a scientific risk assessment by the… - Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
This regulation establishes a centralized authorization procedure for placing genetically modified food and feed on the EU market, requiring pre-market risk assessment by EFSA, traceability, and mandatory labelling of… - Regulation (EC) No 1830/2003 - Traceability and Labelling of Genetically Modified Organisms
Regulation (EC) No 1830/2003 establishes a mandatory traceability and labelling system for GMOs and food and feed produced from GMOs throughout the EU supply chain. Operators must transmit and retain unique identifiers… - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU - Genomic Diagnostics: Class D High-Risk Devices, Performance Studies, Companion Diagnostics, Notified Body Review and EUDAMED Registration
Regulation (EU) 2017/746 establishes stringent requirements for high-risk in vitro diagnostic devices, including genomic diagnostics classified as Class D, mandating Notified Body involvement, performance evaluation… - Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union
Regulation (EU) No 511/2014 implements the Nagoya Protocol access and benefit-sharing compliance obligations for users of genetic resources in the EU. Article 4 requires users to exercise due diligence to ascertain that… - REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Article 6: Validation of Application
This article outlines the mandatory procedures and timelines for a Member State to validate a clinical trial application dossier submitted via the single submission portal, ensuring its completeness before assessment… - Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 28: General rules
Organizations must ensure that for any clinical trial, the anticipated benefits justify the foreseeable risks, this balance is constantly monitored, and subjects or their legally designated representatives are properly… - Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 35: Clinical trials in emergency situations
This article establishes the specific conditions under which informed consent for a clinical trial may be obtained after the first intervention in an emergency situation, derogating from standard consent procedures. - Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 38: Temporary halt or early termination by the sponsor for reasons of subject safety
Sponsors must notify Member States concerned via the EU portal without undue delay, and no later than 15 days, of any temporary halt or early termination of a clinical trial due to a change in the benefit-risk balance. - Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 44: Assessment by Member States
This article requires Member States to cooperate in assessing safety information received from the Agency and to involve responsible ethics committees in this assessment where mandated by national law. - Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 58: Archiving of the clinical trial master file
The sponsor and investigator must archive the clinical trial master file for at least 25 years after the trial's end, ensuring it is accessible, legible, secure, and that all alterations are traceable. - Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 10: Specific considerations for vulnerable populations
Organizations must give specific consideration to the assessment of clinical trial authorisation applications involving vulnerable populations such as minors, incapacitated subjects, pregnant or breastfeeding women, and… - Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 2: Definitions
Organizations must apply the specific definitions for key terms such as 'medicinal product' and 'adverse reaction' from Directive 2001/83/EC when complying with this regulation. - Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 41: Reporting of adverse events and serious adverse events by the investigator to the sponsor
This article mandates that clinical trial investigators must record, document, and report adverse events and serious adverse events to the sponsor within specified timeframes, and that sponsors must maintain detailed… - Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 5: Submission of an application
Sponsors seeking authorisation for a clinical trial must submit a complete application dossier to the relevant Member States via the central EU portal. - Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 79
This article establishes the European Commission's authority to conduct controls to verify Member State supervision and the compliance of non-EU clinical trial regulatory systems, requiring cooperation and the reporting… - Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 8: Decision on the clinical trial
Organizations sponsoring a clinical trial must receive and process the decision notification from each Member State concerned, delivered via the EU portal, which will state whether the trial is authorised, authorised… - Regulation of Biologicals under the Therapeutic Goods Administration (TGA) - Classification, Manufacturing, and Clinical Evidence Requirements for Class 1-4 Biologicals
The TGA Biologicals Framework requires all biologicals (Class 1-4) to be classified based on risk, manufactured under Good Manufacturing Practice (GMP), supported by clinical evidence appropriate to class, and included… - Regulatory overview of therapeutic products in Singapore under the Health Products Act (HPA) and Health Products (Therapeutic Products) Regulations 2016
Therapeutic products must be registered and dealers must hold a valid licence before manufacturing, importing, or supplying such products in Singapore. Registration, licensing, and post-market vigilance including… - Singapore Biosafety Guidelines for Research on Genetically Modified Organisms (GMOs) and for Release of Agriculture-Related GMOs
The GMAC guidelines establish biosafety requirements for research involving GMOs and for the commercial release of agriculture-related GMOs in Singapore. These apply to researchers, institutions, and businesses… - South Africa NHREC Ethics in Health Research Guidelines 2024 - Biobanking and Genomics
The South African Ethics in Health Research: Principles, Processes and Structures Guidelines (3rd edition, 2024) are issued by the National Health Research Ethics Council (NHREC) under the National Health Act 61 of 2003… - Switzerland Federal Act on Non-Human Gene Technology (Gene Technology Act, GTA) of 21 March 2003, SR 814.91
The Swiss Gene Technology Act (SR 814.91) governs handling of genetically modified non-human organisms to protect humans, animals, the environment and biological diversity. Art 1 sets the protective purpose; Art 2… - The Genetic Technology (Precision Breeding) Regulations 2025 (SI 2025/581)
These Regulations operationalise the Genetic Technology (Precision Breeding) Act 2023 in England, requiring a release notice to the Secretary of State at least 20 days before releasing a precision bred organism, a… - UK Animals (Scientific Procedures) Act 1986 (c.14): Licensing of Animal Research
The Animals (Scientific Procedures) Act 1986 (c. 14) regulates the use of protected animals in scientific procedures in the United Kingdom through a three-licence system, administered by the Secretary of State for the… - UK Genetically Modified Organisms (Contained Use) Regulations 2014 - HSE Consent, Risk Classification and Biosafety
The Genetically Modified Organisms (Contained Use) Regulations 2014 (SI 2014/1663) implement EU Directive 2009/41/EC on the contained use of genetically modified micro-organisms (GMMs) in the United Kingdom (retained in… - UK Genome UK Strategy 2020 The Future of Healthcare Genomics England Whole Genome Sequencing Data Sharing Industrial Growth and Public Trust Framework
The United Kingdom Genome UK strategy published by the Department of Health and Social Care on 26 September 2020 establishes the national genomics strategy across diagnosis personalised medicine population genomics and… - UN Convention on Biological Diversity 1992 - Sovereign Rights over Genetic Resources, Access and Benefit-Sharing Obligations, Conservation In Situ/Ex Situ and Technology Transfer Provisions
The Convention on Biological Diversity establishes sovereign rights over genetic resources, requiring states to ensure fair and equitable benefit-sharing from their utilization and to conserve biodiversity in situ and… - US FDA 21 CFR Part 312 - Investigational New Drug (IND) Application for Clinical Trials
21 CFR Part 312 requires sponsors to file an Investigational New Drug Application with FDA before initiating Phase I, II, or III clinical trials in the US - covering investigational biologics, gene therapies, cell… - US GINA - Genetic Information Nondiscrimination Act 2008 - Employment and Health Insurance Protections
The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits discrimination based on genetic information in health insurance (Title I) and employment (Title II). Title I prohibits health insurers from using… - US NIH Genomic Data Sharing (GDS) Policy (2014, updated)
The National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy establishes the expectation that human and non-human genomic data generated from NIH-funded research will be broadly shared in NIH-designated… - US NIH Recombinant DNA Research Guidelines - Institutional Biosafety Committee Requirements
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) govern laboratory research with recombinant DNA and synthetic nucleic acids at institutions receiving NIH… - USA FDA 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
FDA 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products - HCT/Ps) establishes the regulatory framework for human-derived biological materials used in transplantation, therapy, and regenerative… - USA NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2019)
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines, first published 1976, comprehensively revised 2019, administered by the NIH Office of Science Policy - OSP)… - WHO Advisory Committee Human Genome Editing Governance Framework 2021 - Oversight Mechanisms, Registry Requirements and Ethical Principles
This framework establishes global governance standards for human genome editing, including somatic applications, requiring institutional oversight, registration of research, and adherence to ethical principles as… - WHO Laboratory Biosafety Manual 4th Edition 2020 - Risk Assessment, Biosafety Levels 1-4, Containment Requirements, Personal Protective Equipment, Inactivation and Waste Management
This manual establishes a risk-based framework for laboratory biosafety, requiring all laboratories handling biological agents to conduct evidence-based risk assessments prior to activities and implement appropriate… - WIPO Patent Protection for Biotechnology Inventions - Patentability Requirements, Morality Exceptions and Sequence Listing Standards
This WIPO guidance establishes international standards for the patentability of biotechnology inventions, including requirements for industrial applicability, sufficient disclosure, and compliance with morality…
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