Pharmaceutical Group

Links to relevant pharmaceutical professional bodies for the clinical trials supply industry.

The Association of British Pharmaceutical Industry (ABPI)

The trade association for approximately one hundred companies in the UK producing prescription medicines.

The Association of Clinical Research Professionals (ACRP)

A global network of industry leaders dedicated to promoting and advancing the highest standards and practices in clinical research worldwide.

The European Federation of Pharmaceutical Industries and Associations (EFPIA)

An organisation formed to represent the research based pharmaceutical industry operating in Europe.

The Drug Information Association (DIA)

A neutral, global forum that promotes the exchange of information within the pharmaceutical industry.

The Institute of Clinical Research (ICR)

Established in 1978, the Institute of Clinical Research provides a forum for education and sharing of best practice amongst clinical research professionals throughout Europe.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

A non-profit, non-governmental organisation whose member companies are the major global research-based pharmaceutical and vaccine companies.

Medicines and Healthcare Products Regulatory Agency (MHRA)

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

The International Society for Pharmaceutical Engineering

A global, non-profit membership organisation that provides training, education and technical publications to pharmaceutical manufacturing professionals.

The Pharmaceutical Industry clinical trials database

This is a searchable register of retrospective Phase III clinical trials and on-going Phase IV clinical trials in the UK.

The Pharmaceutical Research and Manufacturers of America (PhRMA)

An organisation who represents the United States of America’s leading research-based pharmaceutical and biotechnical companies.

The Royal Pharmaceutical Society of Great Britain (RPSGB)

The regulatory and professional body for pharmacists in England, Scotland and Wales.

 

Regulatory Issues

European Union

Significant changes in European law governing clinical trials came into effect on 1st May 2004. The main aim of the Directive – The Medicines for Human Use (clinical trials) Regulations 2004 – is to simplify the administrative processes governing clinical trials and therefore establish a harmonised procedure for clinical trials throughout the European Community.

Find out more about what this new Directive means in the UK. ADAllen Pharma is licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) to wholesale pharmaceuticals.

 

United States of America

Clinical trials in the USA are regulated by the Center for Drug Evaluation and Research within the Food and Drug Administration (FDA).

Visit www.fda.gov to find out more about the regulations governing trials in the USA.

Leave a comment