GMP News - Regulatory Affairs

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.

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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FDA publishes Draft Guidance on Stability Testing of Generics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.

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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.

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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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01.10.12

EMA recommends first Gene Therapy for Approval

With the recommendation of the authorisation of Glybera, the European Medicines Agency (EMA) recommends the approval of a gene therapy product for the European Union market for the first time. Read more here.

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22.08.12

Continuous Manufacturing - FDA Perspective on Submissions and Implementation

From FDA's point of view, the science exists to enable continuous manufacturing in the pharmaceutical industry and there are no regulatory hurdles for implementing it. However, there is a lack of necessary experience. Read more in this News.

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15.08.12

EMA publishes Video explaining the new Pharmacovigilance Legislation

The European Medicines Agency has produced a video with an introduction to the new pharmacovigilance legislation. Read more.

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14.08.12

GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress

As of 1 October 2012, the FDA can collect fees from generic drug companies for the processing of marketing authorisation applications.The authority can further collect fees for the performance of inspections of generics manufacturers and API suppliers of the generic industry. The reason for this is the enactment on 9 July of the "Generic Drug User Fee Act" (GDUFA) by the Congress. More details about the new act can be found here.

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14.08.12

Revised Guideline on Renewals in the Centralised Procedure Effective!

On 2 July 2012, the revised guideline on renewals in the centralised procedure came into force. Against the background of the Variations Regulation and the new provisions regarding pharmacovigilance, the guideline has been significantly revised and contains new requirements. More details here.

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14.08.12

FDA Approves OTC HIV Test for the First Time

The FDA has approved the first over the counter HIV Test to be performed at home. Read more here.

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01.08.12

Revised Guideline on the ASMF Procedure Coming into Force on 1st October 2012

The "Guideline on Active Substance Master File Procedure" describes the requirements for marketing authorisation holders regarding the ASMF procedure. The revision of this guideline which has been published recently will come into force at the beginning of this year's 4th quarter. Read more here about the coming changes for API manufacturers and the pharmaceutical industry.

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04.07.12

New Guidelines on Good Pharmacovigilance Practices released

The European Medicines Agencvy (EMA) has published two modules of guideline on good pharmacovigilance practices released for public consultation. Read more.

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20.06.12

Revision of the Guidelines on Category Variations to the terms of Marketing Authorisations- EU Commission releases Public Consultation Paper

The detailed guidelines for the categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products are part of the "Variations Regulation" which is in force since the 1st January 2010. These guidelines which describe the categorisation of marketing authorisation variations are being significantly revised. Read more about the draft of the revised guidelines.

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20.06.12

Revised Guideline Draft on Biosimilar Medicinal Products published

At the end of May, the EMA published a draft of the biosimilar guideline from 2006 for comment. This guideline describes the requirements on quality evidence for biosimilar medicinal products. Read more here about the updated instructions.

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16.05.12

EMA - Regulatory procedural Advice on similar biological medicines

In April, the European Medicines Agency published a new document on regulatory procedural advice on similar biological medicines. This guidance should provide help for the applicants to submit applications, which are in conformity with the legal and regulatory requirements. More details can be found here.

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