Transcription of pharmacovigilance requirements for biological products
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pharmacovigilance requirements for biological products
Guidance for industry onpharmacovigilance requirements for biological productsPage 1 of 71 Guidance for industry on pharmacovigilance requirements for biological Products2 PREFACE this is in consonance with the objective of the drugs & cosmetics act 1940 and rules 1945 there under and other functions of cdsco wherever applicable. these guidelines are intended for the guidance of the marketing authorization holders (mahs) manufacturers and importers of biological products . the procedure set out to facilitate the industry to submit the documents as per the requirements of drugs and cosmetics act and rules. Guidance documents may be amended from time to time as per requirements after obtaining necessary approval from the competent central drugs standard control organization (cdsco), being the apex regulatory authority for approval of drugs in india, is committed to safeguard and enhance the Public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical has extensive pharmacovigilance activities for vaccines as part of post licensure submissions in form of Psurs, Pms studies, aefi case reports and individual case safety reports (icsrs) received by PvPi at iPc.
Guidance for industry on PharmacoviGilance requirements for BioloGical Products 2 PREFACE this is in consonance with the objective of the drugs & cosmetics
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