GMP News - Regulatory Affairs

19.09.13

"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.

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19.09.13

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.

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19.09.13

Stability Testing of Generics: FDA publishes Q&A Document

The FDA has published a document with 30 questions and answers to clarify some issues regarding the stability testing of generic products. Read more here about the stability data required for ANDAs.

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01.08.13

Guideline on Labelling and Package Leaflet of Centrally Authorised Medicinal Products Updated

The Commission Guideline on package leaflet of centrally authorised medicinal products has been revised. Read more details here.

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01.08.13

Variations: Important Changes in the New Application Form

As of 4 August 2013 on, a new form for variation applications has to be used. Read more here about what the marketing authorisation holder has to take into consideration.

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15.07.13

EMA updates Q&A Document on Procedures Issues for Holders of a Centralised Marketing Authorisation

The Questions and Answers of the EMA on procedural questions for centralised marketing authorisations have been recently updated and completed with 2 new questions/answers. More details here.

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03.07.13

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.

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03.07.13

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.

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27.05.13

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.

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27.05.13

Approval of combined Advanced Therapy Product

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.

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25.04.13

FDA offers eLearning for eCTD Implementation

The FDA has launched a new service on the website. You can get information on the eCTD topic thanks to Web-Based-Training. Further courses are in preparation. Read more here.

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25.04.13

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.

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25.04.13

CTD Format for Traditional Herbal Medicinal Products

You can find information on where to find the quality requirements on the CTD format for traditional herbal medicinal products in the draft of an EMA/HMPC Guideline. Read more in the News.

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03.04.13

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.

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03.04.13

WHO's New Draft Guideline on Submission of Quality Data for Generic Medicinal Products

A new guideline of the WHO describes the requirements on the quality documentation to be submitted for generic medicinal products. Read more here about the draft guideline.

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