News
FDA: Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events
09.06.2009
This guidance explains:
the content and format of the side effects statement,
where in the Medication Guide to add the side effects statement, and
how to report to the Agency that
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European Commission: Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applicatio
08.06.2009
This guidance document applies only to the coordination of GCP inspections carried out by EU/EEA inspectors in connection with the marketing authorization of medicinal products in the MRP and DCP. ...
HMA: CMD(h) Recommendations for Applications submitted according to Article 10 when the strength and/or pharmaceutical form of the reference medicinal product differs between RMS/CMS(s)
04.06.2009
Article 10.1 concerns products where the particular strength or form of the reference
medicinal product is authorised in the Member State (MS) to which the application is made
(generic). Whereas
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HMA: Recommendation for Mutual Recognition Procedure after finalisation of a referral procedure with a positive decision by the EC
04.06.2009
After submission of the final opinion to the Commission, the Commission will start the Community decision making procedure. This procedure is, in most aspects, the same as the procedure applicable
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FDA: Propylthiouracil (PTU)-Induced Liver Failure
04.06.2009
FDA is notifying healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. ...
EMEA: ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Questions and Answers
03.06.2009
This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering
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MHRA: Concept paper on MHRA project to consolidate and review medicines legislation - outcome published
03.06.2009
The outcome of the concept paper which sought the input of stakeholders into the project on the review and consolidation of medicines legislation has now been published. ...
EDQM: EDQM establishes confidentiality agreements with US-FDA and TGA
01.06.2009
The EDQM has established bilateral confidentiality agreements with the United States Food and Drug Administration (US-FDA) and the Australian Therapeutic Goods Administration (TGA) respectively to
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MHRA: MHRA announces an exercise to update Summaries of Product Characteristics (SmPCs) to include paediatric information following completion of European work-sharing procedures
29.05.2009
Inclusion of paediatric information in marketing authorisations following european work-sharing procedures ...
EMEA: Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice
29.05.2009
This procedural advice addresses a number of questions which applicants may have before submitting an application. The information provided - under the form of Questions and Answers - will be
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