GMP News - Regulatory Affairs

08.07.14

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately. Read more.

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23.04.14

New EMA Guideline on Stability Testing for Applications for Variations

The submission of a variations application for a marketing authorisation often includes the submission of stability data. This is particularly applicable to cases in which critical quality characteristics of the medicinal products are concerned. A new EMA Guideline sets rules to the requirements on different variations scenarios. Read more here.

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23.04.14

EMA: Changes to Handling of Variations

The European Medicines Agency (EMA) is establishing new roles for handling variations. Read more.

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10.04.14

New FDA Guideline on Size, Shape and Physical Attributes of Generics

Companies who want an authorisation for generic tablets or capsules in the USA should consider certain requirements with regard to the physical attributes of these dosage forms. The provisions can be found in a FDA Guidance for Industry recently published. Read more here.

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10.04.14

Post-Approval Changes: new FDA Guidance

The US FDA has published a new guidance on post-approval changes with a new list of changes that might be appropriate to report in an annual report. Read more.

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19.03.14

Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation. Read on.

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28.01.14

"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications

Errors when compiling an application for authorisation for a generic drug in the United States can be really expensive. It is not only important to ensure the completeness of the documents, but also to pay attention to deadlines with regard to various fees. Learn more here.

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28.01.14

Update: Electronic Submission of Marketing Authorisation Dossiers

Since the 1st of January 2010, only electronical submissions for marketing authorisations within the centralised procedure can be accepted. A few significant details about the procedure and the standards have been  recently changed. Read more here about the current requirements for the electronical submission of  dossiers.

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16.10.13

Black Triangle: a New EU Requirement

The use of a black triangle-shaped warning symbol will be required as of January 2014 for drugs containing new APIs and biological products (including biosimilars) to enhance medicinal products safety. More information can be found in the News.

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01.10.13

FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

What do applicants for marketing authorisations of generic products absolutely have to observe is laid down in a FDA Guidance on fees and procedural issues within the framework of the Generic Drug User Fee Act (GDUFA). Read more on the topic.

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01.10.13

EMA gives Clarification to the Variations Guideline in a Q&A Document

The EMA has published a Q&A document to clarify the questions still open with regard to the "detailed guidelines on procedure issues and the classification of variations" associated to the Variations Regulation. Read more here in the News.

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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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