EMEA: Guideline on Summary of Product Characteristics Rev.

This guideline provides advice on the principles of presenting information in the SmPC. Applicants should maintain the integrity of each section of the document by only including information in ...

EMEA: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products in the treatment of depression with regard to treatment resistant depression

There are new proposals with operationalized criteria for TRD available allowing definition of a patient population, which suffers from clinically relevant impairment and requires ...

EMEA: Concept paper on revision of Chapter 7 of the GMP Guide concerning \"outsourced GMP activities\"

The guidance in Chapter 7 is high level and generally still applicable to these other outsourced GMP activities but was drafted at a time when the outsourcing of GMP activities was principally ...

MHRA: Three new publications have been added to the Labels, patient information leaflets and packaging for medicines section

Two BROMI (Better regulation of medicines initiative) audit reports and Code of Practice for pack design for over-the-counter medicines have been added to the Labels, patient information leaflets ...

FDA: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR ...

EMEA: ICH Topic E7 Studies in Support of Special Populations

ICH Topic E7 Studies in Support of Special Populations: Geriatrics - Questions and answers ...

European Commission: Assessment of the functioning of the \"Clinical Trials Directive” 2001/20/EC - Public consultation paper

Requirements for the conduct of clinical trials in the EU are provided for in the “Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the ...

MHRA: Introduction of the Traditional Herbal Registration certification mark

The Traditional Herbal Registration (THR) certification mark is a type of trade mark, indicating that a herbal medicine has been registered with the MHRA under the Traditional Herbal Registration ...

FDA: Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information

This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that ...

FDA: Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by Helicobacter pylori (H. pylori) for the reduction of ...

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