Regulatory Guidelines

Links to authority and industry association websites:

European Directorate for the Quality of Medicines (European Pharmacopoeia, Certificates of Suitability)

FDA- Vaccines, Blood and Biologics

FDA- CDER Biopharmaceuticals Guidance

Australian Therapeutic Goods Administration (TGA)

Japanese Ministry of Health, Labour and Welfare (JMHLW)

Parenteral Drug Association

Plasma Protein Therapeutics Assocaition (PPTA)

European Federation of Pharmaceutical Industries and Associations (EPFIA)

International Plasma Fractionation Association (IPFA)