[Regulatory guidelines and drug safety].
Regulatory prescriptions are essentially safety-oriented. On one hand, they consist of the documentation required for registration, on the other hand, they imply the duty to inform the authorities on side effects, interactions and adverse drug events in the context of postmarketing drug surveillance. Directly addressed to the firms, they are a challenge for every user in the perception of a new drug risk.
Interkantonale Kontrollstelle für Heilmittel (IKS), Bern.
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D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004346:Drug Information Services / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing; D013557:Switzerland