The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes.
The APIC interest group spearheading the effort is developing a comprehensive report that will be made available to member companies, and refined and updated as the knowledge base expands and the regulatory processes evolve.
The process began with a review by selected interest group members of all the relevant laws, guidelines, and regulations for each country. The information was then entered in a standardized electronic template that all interest group members could access.
The next step, recently underway, is a discussion with the regulatory agencies in the emerging countries when a better understanding or clarification is needed. The results of those discussions will also be included in the report, which the interest group views as a living document that will be updated any time new information is received.
At the annual APIC/CEFIC API conference held in Vienna, Austria in early November, DSM Regulatory Affairs Director Jan Smeets provided a review of how the interest group is functioning, the progress of the mapping process, and what the group has learned to date.