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- Keywords > adverse drug reactions (ADRs)
- Keywords > bioequivalent generic products
- Keywords > International Generic Drug Regulators Pilot (IGDRP)
- Keywords > International Nonproprietary Names (INN)
- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > regulatory matters
- Keywords > safety and efficacy
- Keywords > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Keywords > WHO certification scheme
- Keywords > WHO International Drug Monitoring Programme
(2016; 186 pages)
The third issue for 2016 includes featured articles on the following topics:
Regulatory collaboration: A regulatory gap analysis survey among members of the International Generic Drug Regulators Pilot (IGDRP) has identified commonalities and differences that might create challenges for work-sharing and collaboration. The main gaps were related to the definition of a generic drug product, the selection of international reference products for use in bioequivalence studies, criteria for granting biowaivers, requirements to use national or regional pharmacopoeias, and the minimum stability data to be included in marketing authorization applications.
Generic medicines: Adjusted indirect comparisons of bioequivalence data for WHO-prequalified generics suggest that the products can largely be considered as clinically interchangeable not only with the comparator product, but also among themselves. Recommendations are provided for regulatory assessment of generics and possible harmonization approaches in WHO Member States, including those with limited regulatory capacity.
Adopted guidance: This section comprises the revised Questions and Answers (Q & A) document on the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, as adopted by the Expert Committee for Specifications on Pharmaceutical Preparations at its 50th Meeting in October 2015. The Scheme enables its member states to request certain information from other members by means of defined documents, notably the Certificate of Pharmaceutical Product (CPP).
The Safety news section highlights information on adverse drug reactions and recommendations including labelling changes, as well as findings of non-compliance with good practices and falsified product alerts. The Regulatory news section gives an overview of developments at regulatory authorities, particularly those having an impact on decision-making and risk assessment, as well as approvals of products. This is followed by a news section on Publications and events related to medical product access, quality and use in WHO Member States.
The Consultation documents section includes draft active substance and/or finished product monographs for chlorhexidine digluconate, medroxyprogesterone acetate, clindamycin palmitate, clindamycin phosphate, ceftriaxone, mebendazole and methylthioninium, as well as a proposed revision of the general chapter 1.11, Colour of liquids, for The International Pharmacopoeia.
The issue concludes with List No. 76 of recommended International Nonproprietary Names (INN).