U.S. federal agencies should strengthen their regulatory review processes for emerging biotechnology products to align with public and stakeholder priorities, including health, environmental, and socio-economic parameters.

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture

Biotechnology policies across countries are similar, with government support for R&D and capital investment, and minimal non-tariff barriers to trade.

International Comparisons of Biotechnology Policies

Different jurisdictions have different approaches to regulating agricultural biotechnology safety, with political divisions causing disagreements on appropriate triggers for regulatory capture.

A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

The US legal policy on modern biotechnology trade and patent relations impacts agricultural production systems and exports, with a focus on genetically modified products and patent relations.

FUNDAMENTALS OF THE US LEGAL POLICY ON TRADE IN PRODUCTS OF MODERN BIOTECHNOLOGY

The Pan-American Health Organization (PAHO) is working to harmonize biotechnological and biological product regulation in Latin America and the Caribbean, addressing the growing demand for licensing applications.

Review of regulation of biological and biotechnological products in Latin American and Caribbean countries.

Biotechnological medicines may undergo a separate and parallel regulatory process to other medicines, with additional oversight by institutions like Institutional Biosafety Committees and National Regulatory Authorities.

Institutional Biosafety Committees and Regulation of Genetically Modified Organisms

The regulation of biological products requires new regulations to adapt to molecular biology and recombinant technology, while maintaining the protection of recipients.

The regulation of biological products

The EPA's proposed biotechnology regulation plan has sparked a flood of responses from researchers, industry, and environmental groups, with many questioning the agency's intention to subject genetically engineered products to more rigorous scrutiny than conventionally manufactured products.

Biotech policy draws flood of comments.

India's biotechnology development is expanding and its biosafety regulations need harmonisation with other countries in the region to protect the environment from hazardous genetic engineering products.

India's biotechnology policies and biosafety regulations

Product regulation plays a crucial role in stem cell research's clinical translation, with regulatory reform, fragmentation, and capacity being key challenges.

Product Regulation and the Clinical Translation of Stem Cell Research

The U.S. is preparing to modernize agricultural biotechnology regulations to address new gene-editing methods and clarify the roles of federal agencies in ensuring safety.

SCIENCE POLICY. U.S. to review agricultural biotech regulations.

Biologic product approval in the US, Canada, Europe, Australia, and Singapore differs from each other, requiring manufacturers to carefully assess market interest, expenditures, target zones, and regulatory standards before establishing biologics.

A Comparative Study of Biologic Regulation in US, Canada, Australia, Europe and Singapore

Labeling biotechnology consumer products with a simple alert label is recommended to encourage producers and others to effectively convey information to consumers, rather than just conveying substantive information.

An Information-Based Approach to Labeling Biotechnology Consumer Products

European biotechnological product developers should avoid common pitfalls in marketing authorization applications by addressing regulatory concerns and implementing best practices.

Typical pitfalls in applications for marketing authorization of biotechnological products in Europe

Nonclinical evaluation of biotechnology-derived products is crucial for regulatory compliance and managing potential risks, with technical guidelines from the International Conference on Harmonisation being useful for global development.

Legal and Scientific Considerations in Nonclinical Assessment of Biotechnology Products

The revised Common Rule may not fully address biospecimen research concerns, and the question of whether biospecimens should be considered inherently identifiable remains unresolved.

Regulating Research with Biospecimens under the Revised Common Rule.

Medical products using biomaterials face diverse global regulatory constraints, with common controls including registration, premarket approval, and reporting adverse events, but methods of control vary significantly.

Regulatory Constraints for Medical Products Using Biomaterials

Countries, but not in developing countries, as the International Conference on Harmonisation's guidelines are often used for private research conducted in industrialized countries.

Ethical oversight of research in developing countries.

What are the regulations and policies governing biotechnological research and products?

These studies suggest that biotechnological research and products are governed by a variety of regulations and policies, including strengthened regulatory review processes, harmonization efforts across regions, and specific oversight for genetically modified and biological products.