Pharmaceutical Regulation and Industry
Global drug regulatory dynamics, policy interpretation, and analysis of the development trend of the pharmaceutical industry
EMA Updates Guideline on Pediatric Investigation Plans
The European Medicines Agency has published a revised guideline on PediatricInvestigation Plans, with new requirements for age-appropriate formulations andlong-term safety data collection.
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EMA Releases Guidance on Regulatory Framework for AI Medical Devices
The European Medicines Agency (EMA) has released its long-awaited guidance on the regulatory framework for artificial intelligence and machine learning medical devices (AI/ML MD)
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Animal Biologicals
Animal biologicals are subject to both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the United States Department of Agriculture Animal Health
View DetailsAnimal Biologicals
Animal biologicals are subject to both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the United States Department of Agriculture Animal Health
View DetailsApproved Animal Drug
Most FDA-approved animal drugs are included in a publicly available list of approved animal drug products. This list is called the Green Book for short, and FDA updates it
View DetailsRegulatory Agency
World Health Organization (WHO)
The World Health Organization (WHO) plays a leading role in global drug regulatory coordination, formulating international drug standards and guidelines, promoting the building of drug regulatory capacity, and enhancing global drug accessibility.
Pharmaceuticals and Medical Devices Agency (PMDA)
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for the review and approval of drugs and medical devices, post-market safety monitoring, and clinical trial supervision.
National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is responsible for the registration and approval, production and circulation supervision, and quality and safety management of drugs, medical devices, and cosmetics in China. In recent years
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is the EU's drug regulatory authority, responsible for evaluating and supervising the marketing authorization and safety monitoring of drugs within the EU
International Council for Harmonisation (ICH)
ICH is an international organization composed of representatives from major global drug regulatory authorities and the pharmaceutical industry, dedicated to coordinating technical requirements for global drug registration
U.S. Food and Drug Administration (FDA)
The US FDA is one of the most influential drug regulatory agencies globally, responsible for protecting and promoting public health, and overseeing the safety and effectiveness of products such as drugs, medical devices, food, and cosmetics.