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.
EDQM restricts the Acceptance of Substances for New CEP Applications
Strict requirements have to be complied with when submitting a dossier for the application of a new CEP. Read more about the changes recently published in a revised Policy of the EDQM on restrictions regarding substances.
European Medicines Agency recommends approval of first vaccine for meningitis B
Until today, there was no no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B. Now, the CHMP provided a recommendation for such a vaccine for the first time. Read more here.
FDA publishes Draft Guidance on Stability Testing of Generics
In the near future, extensive stability data on the medicinal product and the API should be submitted for the application of generics in the USA. The FDA has recently published a draft guideline for comment. More details about the new requirements can be found here.
Generic Drug Applications in the USA: Completeness Assessment of Drug Master Files for APIs by the FDA
The GDUFA (Generic Drug User Fee Act), the new fees regulation on generic drug applications, is valid in the USA as of 1 October 2012. One part of this legislative regulation is a completeness assessment of the Drug Master File, the generic drug application refers to. This has significant effect on the applicant. Go here for more information.
EMA explains EU Incident Management Plan for Human Medicines
The EMA has published the European Union regulatory network incident management plan for medicines for human use, explaining how the EMA, the European Commission and medicines regulatory authorities work together in the EU Member States. Read more.