Atypical APIs
The Commission and the EMEA have recognised that for a small number of medicinal products the primary use of the active substance is not in a medicinal product and the producer may therefore not be aiming to meet the specific requirements of pharmaceutical customers that represent an insignificant volume of business. This issue has been the subject of discussions between the Commission/EMEA and various industry groups for some time. In September 2008 the EMEA issued the following advice on the Q&A section of their website on how to proceed when dealing with an ‘atypical’ active:
“Alternative sources should normally be sought but in exceptional circumstances the manufacturing authorisation holder should assess and document to which extent GMP is complied with and provide a risk-based justification for the acceptance of any derogation. The declaration provided by the Qualified Person should set out in detail the basis for declaring that the standards applied provide the same level of assurance as GMP. EMEA will collect experience with this approach which can be used as a basis for discussion on related amendments to guidelines in the future.”
This is a pragmatic solution that has generally been welcomed by industry.
Tags: APIS, Regulation