MHRA: Special Mail 5: Frequently Asked Questions (version 2.1 - June 2009)

The guidance in Special MAIL 5 includes that for submitting new MA applications, MA variations and Clinical Trial applications. For MA applications and variations, it is expected that this ...

FDA: Q8(R1) Pharmaceutical Development Revision 1

This guidance is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that published in May 2006. The Q8 parent guidance is revised to add an annex, which provides ...

EMEA: CVMP Guideline on Eudravigilance veterinary XML Schema Definition (XSD) (CVMP adopted March 2004) - Version 2.2.1

This document describes the electronic standard to exchange safety reports on adverse reactions to veterinary medicinal products. It is based on the EMEA Guieline Data elements for the electronic ...

EMEA: Draft documents for Community Herbal Monograph

Community Herbal Monograph on Valerianae radix and Lupuli flos Valeriana officinalis L., redix and Humulus lupulus L., flos (valerian root and hop strobiles) ...

FDA: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products

FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device ...

FDA: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application

This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine whether research studies can be conducted under 21 CFR 361.1, ...

FDA: Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events

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 ...

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

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)

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 ...

HMA: Recommendation for Mutual Recognition Procedure after finalisation of a referral procedure with a positive decision by the EC

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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