Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Relevance of a Certificate of Pharmaceutical Product for registration and Life Cycle Management of imported Drugs. How is the WHO Certification Scheme implemented by National Health Authorities outside of the ICH? ***

Anna Sahl (Abschlußjahr: 2013)

Summary

Language: English

The Certificate of Pharmaceutical Product (CPP) within the WHO Certification Scheme is described and its relevance for the approval of New Drug Applications (NDAs) and Life Cycle Management (LCM) of imported finished medicinal product registrations is evaluated.

In order to evaluate this some selected countries were contacted via the Local Regulatory Affairs Managers (LRAM) working in the pharmaceutical sector on NDA and maintenance activities in Regulatory Affairs. A questionnaire on the use and need of CPPs as specified for each country regulation was created and LRAMs were asked to answer the questions according their ‘every day working experiences’ including the country regulations in their country.

During the evaluation of the answers of the representative countries, varying from small countries with small Health Authorities (HAs) up to fast growing economies with larger HAs, it was concluded that the potential of the WHO Certification Scheme to improve the efficiency of drug evaluation is not fully exploited by HAs in countries outside the ICH, even though they decided actively to participate in the WHO Certification Scheme. The countries require certifications, such as CPPs, as mandatory supplements to NDAs or supplemental registrations in variation submissions, even though their HA also review the Quality, Safety and Efficacy completely.

Due to this kind of requirement, a delay in the approval of new innovative therapies is often the result. The WHO Certification Scheme was initially created to accelerate the availability of innovative new drugs in developing countries. The conclusion drawn by this evaluation is that the CPP as a mandatory document for filing and approval of a NDA does not really improve the review time by local HAs. The WHO, HAs and stakeholders involved to this business collaboration should work to improve acceptance and handling of the WHO Certification Scheme internationally, since the growth and development in emerging markets seem to take even less advantage of the system while the resources and knowledge is in progression.

Pages: 46, Annexes: pages : 76