News
EMEA: Substances considered as not falling within the scope of the MRL Regulation
30.09.2009
This document supersedes the List of Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90 (EMEA/CVMP/046/00-Rev.16), and was adapted to take account of the
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HMA: CMD(h) Best Practice Guide on the use of eCTD in the MRP/DCP
30.09.2009
Further to experience gained both by Industry and National Competent Authorities, the CMD(h) has developed guidance to facilitate the use of eCTD as the submission format in the MRP and DCP. This
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HMA: Requests to act as RMS in DCP
30.09.2009
Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures. ...
EMEA: Questions and answers on the review of bisphosphonates and the risk of osteonecrosis of the jaw
28.09.2009
The European Medicines Agency has completed a review on the risk of osteonecrosis (death of bone tissue) of the jaw associated with the use of bisphosphonates. The Agency’s Committee for
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European Commission: Implementation of the Advanced Therapies Regulation
24.09.2009
Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
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European Commission: Notice to Applicants, Volume 2C Guidance on Summary of Product Characteristics (SmPC)
24.09.2009
Notice to Applicants, Volume 2C, the guidance document on Summary of Product Characteristics (SmPC) has been updated. It will apply as from 1 May 2010 but submissions in accordance with the
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EMEA: ICH Topiq Q8 (R2) Pharmaceutical Development - Note for guidance on pharmaceutical development
24.09.2009
This guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical
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Polish Ministry of Health: Regulation project relating to Braille
24.09.2009
Regulation project relating to put the Braille on the packaging of the specific types of the medicinal products. ...
FDA: Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation
21.09.2009
The purpose of this guidance is to inform industry of the Food and Drug Administration’s (FDA’s) current thinking regarding the types of microbiological studies, assessments, and clinical
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European Commission: Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)
21.09.2009
This concerns an update in EudraLex. The old XML files (dated March 2007) of the electronic application form in EudraLex (form-new, form-variation, form-renewal) should be replaced by the new XML
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