Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Overview of the Active Substance Master File Approaches in the European Union, Japan, Brazil, Russia and the World Health Organization from the Perspective of an API Manufacturer of Small Molecules

Cornelia Wagner (Abschlußjahr: 2016)

Summary
Language: English
Pharmaceutical companies seek global regulatory strategy for marketing authorisation applications of their medicinal products. The main markets with highly regulated environment are the EU Member States, the United States of America (USA) and Japan. However, from the business perspective the emerging markets are most interesting for growth. The fastest growing countries are summarized as the BRICS countries standing for Brazil, Russia, India, China and South Africa. The final Marketing Authorisation Holder quite often does not produce the API(s) by itself but purchases them from other companies from all over the world. In such a globalized environment the API manufacturer can only overview the supply chain up to its direct customer. The quality of the medicinal product is mainly determined by the quality of the API(s). Due to the key role of the API in a medicinal product it could be in the interest of the API manufacturer to protect its intellectual property of manufacturing. Another aspect is the administrative workload of repetitive submissions and assessments of the same documentation in a country or region because an API is used in multiple medicinal products. To do so, it is very important to know which regulatory requirements and procedures exist in the markets.
In this thesis, the subject is the active substance master file approach for human medicinal products in the European Union, Japan, Brazil, Russia and the World Health Organization (WHO).
The following topics are analyzed: approach of the API regulations, content, format of DMF, pharmacopoeia, submission and review procedure, conduct of GMP inspections. Purpose of the thesis is to support the API manufacturer in its process of decision making by providing the main characteristics of the documentation and procedures.
Regulatory activities in international countries can be efficient and successful by all means. However, regional and country-specific aspects discussed in this thesis are to be taken into account in good time for enabling good decisions for economic success and regulatory compliance.
Pages: 47                 Annexes:-