Article archive

Update: Electronic Submission of Marketing Authorisation Dossiers

28/01/2014 23:51
"How and to whom shall I submit my dossier?" - this question is No 28 of EMA's Q&A document on procedural issues in the context of the centralised procedure ("Pre-authorisation Procedural Advice for Users of the Centralised Procedure"; EMA/339324/2007). The answer to this question was updated...

How to submit an Active Substance Master File?

22/01/2014 23:47
As part of the authorisation procedure for a medicinal product, applicants have to provide detailed information about the quality of the API. Generally, the applicant doesn't manufacture the API himself but receives it from an API manufacturer and has to submit  the quality-related information...

Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published

22/01/2014 23:44
In November 2013 the European Committee on Blood Transfusion (CD-P-TS) of the Council of Europe adopted the Good Practice Guidelines for Blood Establishments and Hospital Blood Banks Required to Comply with EU Directive 2005/62/EC” during its plenary session. It will replace the "Appendix 1:...

FDA 2013 Review

15/01/2014 23:40
The last year was a difficult year for the U.S. Food and Drug Administration. For quite a long time, Republicans and Democrats couldn't agree on a spending plan for the fiscal year 2014, which just started on 1 October. On September 17, 2013, the Office of Management and Budget (OMB) sent out a...

Implementation of Good Distribution Practices: Explanatory Notes from MHRA

15/01/2014 23:37
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. The document should be read alongside with the GDP Guide for better understanding. Summary of a few points from the MHRA...

European QP Association: New Q&As published

15/01/2014 23:35
At the QP Forum of the European QP Association (EQPA) last November in Lisbon a Q&A Session was carried out. During the two days of the Forum, delegates were able to address questions to the speakers and the Advisory Board. Those were answered in a dedicated session. However, time did not allow...

Summary of the new EU GMP Chapters and Annexes

15/01/2014 23:29
The last year was an interesting year for those who have to have an eye on GMP regulations in the European Union. The EU GMP Guide is under constant revision. Here is an overview: Effective since January 2013 is Chapter 1 Pharmaceutical Quality System and Chapter 7 Outsourced...

EMA now also issues GMP and GDP Non-Compliance Information

08/01/2014 23:24
The U.S. Food and Drug Administration FDA has been communicating GMP non-compliance issues in their Form 483 or in Warning Letters. Under the Freedom of Information Act, those documents have been accessible to the public for a long time. So far, EU inspectorates did not publish any results of their...

USP proposal on temperature control during storage and distribution

08/01/2014 22:58
The USP has published a so called stimuli article which is intended to provide a proposal to revise an existing USP monograph. The article provides a brief overview of drug product stability studies and practices with focus on temperature control during storage and distribution. The authors...

GMP for Radiopharmaceuticals - existing and expected Guidelines

08/01/2014 22:56
In August 2013, the PIC/S published their annual report 2012. Amongst other topics, they informed in section 38 that the Working Group on Annex 3 to PE 010 to the PIC/S Guide to Good Practices for the Preparation of Radiopharmaceuticals in Healthcare Establishments (PE 010) held its 3rd...
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