Search results with tag "Safety and efficacy"
Medicinal products quality, safety and efficacy - Trends
academy.gmp-compliance.orgEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medicinal products – quality, safety and efficacy Brussels, 12 October …
CDSCO - Guidance for Industry
www.cdsco.nic.in•Submission of Clinical Trial Application for Evaluating Safety and Efficacy • Requirements for permission of New Drugs Approval • Post approval changes in biological products: Quality safety and Efficacy Documents • Preparation of the Quality Information for Drug Submission for New Drug Approval:
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
www.ema.europa.euThe safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available. b In case of delay, the booster should not be given later than 24 months of age. c See section 5.1. The need for and timing of further booster doses has not yet been determined. d See section 5.1.
GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC ...
www.who.intPage 4 the licensing of these products will facilitate development of and worldwide access to biotherapeutics of assured quality, safety and efficacy at more affordable prices.
Medicines Control Council : General Information
www.kznhealth.gov.zameet technical requirements of quality, safety and efficacy of the product for the purposes for which it is intended. The Guidelines are meant to guide the applicant in meeting the requirements of the Act. It is acknowledged, however, that in some instances scientific developments may …