Important Links

Regulatory Authorities

Israeli Minisrty of Health (MOH)

Directorate of Medical Technologies, Informatics & Research, Clinical Trials

Food & Drug Administration (FDA).

The US regulatory agency for food, drugs, biologics, and medical devices

European Medicines Agency's (EMA).

The regulatory EU agency for drugs and biologics

Therapeutic Goods Administrationing (TGA).

The Australian regulatory agency for drugs, biologics, and medical devices

Medicines and Healthcare Products Regulatory Agency (MHRA)

The UK regulatory agency for drugs, biologics

Regulatory Requirements and Standards

International Council for Harmonisation (ICH)

ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical requirements of pharmaceuticals for human use, developed into ICH guidelines to achieve greater worldwide harmonization.

United States Pharmacopoeia (USP)

Public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods that help to improve global health.

European Pharmacopoeia (Ph. Eur.)

The European Pharmacopoeia is a single reference work for the quality control of medicines. The official standards it contains provide a scientific basis for quality control during the entire life cycle of a product.

Regulatory Associations

Drug Information Association (DIA)

Providing invaluable forums to exchange of vital information and knowledge and discuss current issues related to healthcare products and technologies development.

Parenteral Drug Association (PDA)

A leading global nonprofit organization, provider of science, technology, and regulatory information to advance pharmaceutical/biopharmaceutical manufacturing science and regulation.

Clinical Trials

ClinicalTrials.gov

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. This registry of clinical trials is run by the United States National Library of Medicine at the National Institutes of Health, and is the largest clinical trials database in the world.

EudraCT - EU Clinical Trials Registry

The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA)

CenterWatch

CenterWatch has been the recognized global leader in providing clinical trials information to professionals working at sponsors, CROs, research sites and niche service providers.

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