This site is a centralized resource of publicly-available information for all active pharmaceutical ingredients currently used in contraceptive products, including physical and chemical properties, toxicology, biochemistry and pharmacology, metabolites, chemical impurities, usage in medical products, and analytical methods used for testing.

The British Pharmacopoeia is the official, authoritative collection of standards for UK medicinal substance. It is produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare Products Regulatory Agency, and updated annually.

The European Pharmacopoeia defines requirements for the qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production.

The International Pharmacopoeia was developed by the World Health Organization (WHO) as a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients, and dosage forms that is intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmaceutical requirements.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

This guideline on good pharmacovigilance practice contains chapters on major pharmacovigilance processes and on product- or population-specific considerations. Good pharmacovigilance practices are a set of measures to facilitate the performance of pharmacovigilance in the European Union.

The Uppsala Monitoring Centre (UMC) carries out the World Health Organization’s Programme for International Drug Monitoring. Since 1978, UMC has managed primary aspects of the expanding worldwide pharmacovigilance network of the now more than 130 countries.

This brief includes questions and answers about the World Health Organization (WHO) Prequalification Programme, which facilitates access to medicines that meet unified standards of quality, safety, and efficacy.

The World Health Organization (WHO) Model Lists of Essential Medicines, which serve as guides for the development of national and institutional essential medicine lists, are updated and revised every two years by the WHO Expert Committee on Selection and Use of Medicines.

The World Health Organization (WHO) Prequalification Programme facilitates access to medicines that meet unified standards of quality, safety, and efficacy. This site includes information for applicants.

ANSI is a private, non-profit organization that administers and coordinates the U.S. voluntary standards and conformity assessment system.

ASTM International is a globally recognized leader in the development and delivery of international voluntary consensus standards. ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.

ISO (International Organization for Standardization) is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards.

The IPEC Federation is a global organization that promotes quality in pharmaceutical excipients. The IPEC Federation represents the four existing regional International Pharmaceutical Excipient Councils (IPECs) - IPEC Americas, IPEC Europe, IPEC Japan and IPEC China - and provides a unified voice to promote the best use of excipients in medicines as a means of improving patient treatment and safety.

This paper provides an overview on drug impurity. Impurity is a word that is used frequently in discussions about drug quality. This paper looks at what impurities are and how they can affect product quality.

This searchable database contains the current general and permanent rules of the U.S. Food and Drug Administration, also known as Title 21 of the U.S. Code of Federal Regulations.

This site, from the National Institute of Allergy and Infectious Diseases, provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries.

This site, from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) serves as a platform to bring together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration and provides updates from the council.

This website, Regulatory Resources for Africa, offers a single platform for sharing country-specific policies, regulations, guidelines, fees and processes for registering medicines in 32 African countries. Development of this site was made possible through the Innovative Pharmaceutical Association South Africa.

This guide from WCGCares sheds light on the complex, evolving regulatory requirements and processes of different countries, providing global health program managers lack the regulatory knowledge needed to plan for registration as a part of new contraceptive product introductions. The goal of this guide is to demystify regulatory affairs for non-experts, giving readers the basics of product registration and how this information can support good decision-making by program managers in consultation with regulatory experts.