WHO Drug Information
Volume 31, N° 3, 2017
The third issue for 2017 includes featured articles on the following topics:
- Regulatory systems in India
India has emerged as a major supplier of medical products globally. This article gives an overview of the regulatory system in India and some recent initiatives aiming to make regulatory operations more efficient to ensure effective control and facilitate cooperation with other agencies.
- Prequalification process quality improvement initiatives: 2010–2016
In the past six years the WHO Prequalification Team (PQT) has organized a total of four surveys to evaluate client satisfaction among manufacturers that have applied for prequalification of their medicines, vaccines or in vitro diagnostic products. This article provides an overview of the survey findings and some other initiatives to improve prequalification process quality.
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. The Regulatory news section gives an overview of developments at regulatory authorities, topics under discussion through public consultations, and approvals of products. This is followed by a section on Publications and events related to access, quality and use of medical products in WHO Member States.
The Consultation documents section presents the following proposed texts:
- For The International Pharmacopoeia: monographs on ganciclovir, ganciclovir for injection, protionamide tablets, norethisterone enantate, norethisterone enantate injection, ciclosporin and dacarbazine and proposed texts on Replacement of mercury salts in non-aqueous titration and on Polymorphism
- Medicines quality assurance: Proposal for updating the definition of “stringent regulatory authority”.
These and other working documents are available for comment at:
Issue 3 concludes with List No. 78 of recommended International Nonproprietary Names for Pharmaceutical Substances (INN).