Making science work

Target groups

The seminar may be supportive for regulators working on CMC approvals for these countries, quality functions to support registrations and authors in Operations and Development who prepare key documents for Emerging Markets.

Objective

The increasing economic importance of the Emerging Markets in Asia and Latin America, for instance, has led to submissions of marketing authorization applications close to submissions in classical 1st wave countries. It is more and more an economic need to be present in these Emerging markets to compensate the slow growth in Europe, Japan and North America, for instance. Under these so called BRIC countries the most promising are China, Russia and Brazil.

These countries do not follow completely the ICH guidelines, although, China and Brazil are ICH members. Instead, country specific requirements are developing rather dynamic and therefore require more attention and resources to fulfil regulatory needs. The overall objective of this seminar is to explain the most important processes and requirements regarding CMC to submit and update a dossier successfully in China, Russia and Brazil. It explains e.g. China’s regulatory processes, the review process of National Medicinal Products Administration (NMPA) for MAAs and the tasks of the National Insitute for Drug Control (NIFDC). For Russia and Eurasian Economic Union (EAEU), the regulatory processes and the content of the Normative Document are presented. For Brazil, i.a. the role of ANVISA is explained as well as the most important CMC requirements.