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GMP: EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use

20.07.2011
The Guidelines laid down in Article 84 of Directive 2001/83/EG on Good Distribution Practice (Document 94/C 63/03) haven\'t been changed since their first publication in the Official Journal of ...

EMA: Guidance for companies seeking scientific support and advice on traditional herbal medicinal products

20.07.2011
The following guidance has been established for companies who may want to seek scientific support and advice from the Committee on Herbal Medicinal Products (HMPC) on traditional herbal medicinal ...

EMA: Procedure on the publication of HMPC public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof are not established

20.07.2011
This procedure has been prepared to clarify the conditions when the Committee on Herbal Medicinal Products (HMPC) shall establish a public statement on an herbal substance which was on the HMPC ...

GMP: FDA publishes Draft Guidance on Classification of Products as Drugs or Devices

13.07.2011
Based on the number of requests from manufacturers addressed to the Agency concerning the classification of their products as a drug or a device, the FDA published a new guidance which should help ...

GMP: FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices

06.07.2011
The aim of the new Guidance is to inform reviewers - in the premarket application process for medical devices (510k, PMA, HDE processes) and for clinical studies (IDE process) - about the latest ...

GMP: Directive 2011/62/ of the European Parliament on the Community code relating to medicinal products for human use

01.07.2011
Directive 2011/62/ of the European Parliament and of the council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the ...

FDA: Q11 Development and Manufacture of Drug Substances

28.06.2011
This guideline describes approaches to developing process and drug substance 66 understanding and also provides guidance on what information should be provided in 67 CTD sections 3.2.S.2.2 – ...

GMP: New ICH Q11 Guideline published

21.06.2011
On June 16, 2011 the ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) was published as a Step 3 document This ...

FDA: Guidance for Industry Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics

16.06.2011
The purpose of this guidance is to provide recommendations to applicants on endpoints for non¬21 small cell lung cancer (NSCLC) clinical trials submitted to the Food and Drug Administration 22 ...

EMA: Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance

06.06.2011
This concept paper addresses the need to develop guidance on process validation of biotechnology derived active substances. ...

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