"Sister File Procedure": New Fast-Track Procedure for the Application of Further CEPs for the Same API
How to apply for a second or third additional Certificate of Suitability for the same API? The EDQM has released a guideline on the topic. Read more about how the so-called "Sister File" procedure works.
Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files
Which APIs stability information is required for a US Drug Master File within the marketing authorisation application of generic product? Read more about what DMF holders and applicants have to take into consideration in this context.
WHO publishes Variations Guideline for Prequalified APIs and Medicinal Products
The new WHO Variations Guideline lays down the requirements for the variations categories and applications for the manufacture and examination of prequalified APIs and medicinal products. Read more about the new regulation.
Final Variations Guideline on Procedures Issues and Classification of Variations published
The two guidelines on procedures and categories of variations have been recently combined in an updated document. More details about the "Variations Guideline" recently published on the Commission Website can be found here.
Important Information for Generics Manufacturers: Self-identification for Fiscal Year 2014 will close on 1st June 2013!
Holders of an authorisation for generic drugs in the USA are required to comply with the annual deadline for the submission of their self-identification to the FDA. The deadline for fiscal year 2014 ends on 1st June 2013. Read more here.
With a press release dated from 26 April, the European Medicines Agency (EMA) announced the CAT and Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of a combined advanced-therapy product. Read more.
EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations
EMA's "procedural advice" documents provide important recommendations and answers to questions about the centralised procedure for medicinal products. These documents have been recently brought up to the current state of the art. Read more here.
Simplification of Application Submissions for Centrally Authorised Products
Submitting an application for a centrally authorised product is a complex procedure. Now the EMA has simplified this procedure through new regulations and presented them in an updated guide. Read more here.