Regulatory Guidelines

Related to biosafety of biopharmaceutical products

Links to regulatory authority and industry association websites are provided below. If you need assistance in navigating specific regulatory guidelines for your processes, connect with a ViruSure team member for assistance.

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Regulatory Guidelines
European Medicines Agency (EMA)
International Council for Harmonization (ICH) Quality Guidelines
FDA-Vaccines, Blood and Biologics
Center for Biologics Evaluation and Research (CDER)
Australian Therapeutic Goods Administration (TGA)
Japanese Ministry of Health, Labour and Welfare (JMHLW)
Korean Ministry of Food and Drug Safety (MFDS)
Parenteral Drug Association (PDA)
Plasma Protein Therapeutics Association (PPTA)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
International Plasma Fractionation Association (IPFA)