GMP News - Regulatory Affairs

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

28.02.13

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.

28.02.13

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.

11.10.12

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.

11.10.12

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.

01.10.12

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.

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26th APIC/CEFIC Global GMP & Regulatory API Conference - in Berlin or online

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25/26 October 2023

GMP News - Regulatory Affairs

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

WHO publishes Variations Guideline for Prequalified APIs and Medicinal Products

Final Variations Guideline on Procedures Issues and Classification of Variations published

Important Information for Generics Manufacturers: Self-identification for Fiscal Year 2014 will close on 1st June 2013!

Approval of combined Advanced Therapy Product

FDA offers eLearning for eCTD Implementation

EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations

CTD Format for Traditional Herbal Medicinal Products

Simplification of Application Submissions for Centrally Authorised Products

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

EDQM restricts the Acceptance of Substances for New CEP Applications

European Medicines Agency recommends approval of first vaccine for meningitis B

FDA publishes Draft Guidance on Stability Testing of Generics

Generic Drug Applications in the USA: Completeness Assessment of Drug Master Files for APIs by the FDA

EMA explains EU Incident Management Plan for Human Medicines

Recommended Event

26th APIC/CEFIC Global GMP & Regulatory API Conference - in Berlin or online

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