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  • Quality guidelines support the legislation for pharmaceutical products, and assist in the assurance that a patient receives a product of appropriate quality.
  • To protect patient health, global standards for quality should be applied throughout the world.
  • Based on specific expertise and commitment to public health, the IFPMA collaborates with WHO and regulatory bodies in the development and the implementation of quality guidelines.
  • The IFPMA supports the WHO/UN Pre-qualification Program that facilitates the assessment of quality of medicines (including vaccines) and laboratories for United Nations agencies, international organizations and countries interested in the bulk procurement of pharmaceutical products used for HIV/AIDS, tuberculosis, malaria, and reproductive health in developing countries.

Background

Quality guidelines provide direction to those involved in the development, manufacture and supply of medicines to assist them in assuring that the quality of the medicine achieves the safety and efficacy that have been established through clinical trials. They ensure that both regulators and the industry have a mutual understanding of the requirements.

Patients in all countries have a fundamental right to receive medicines meeting global standards of quality. Development of globally harmonised guidelines contributes to meeting this expectation.

It is the aim and the responsibility of the pharmaceutical industry in terms of product development, clinical trials , global manufacturing and global sales to facilitate the provision of products meeting global quality standards. To match these objectives, an essential factor is the availability and the implementation of globally consistent guidelines. Since 1990 there has been an initiative to harmonise regulatory guidelines in Europe, USA, and Japan, which since the beginning have been supported by pharmaceutical industry and IFPMA. However, as the majority of countries are outside these ICH  regions a specific cooperation has started with those regions beyond ICH  (i.e. ICH Global Cooperation Group (ICH GCG)). The WHO also initiated, more than 60 years ago, a program for the development and maintenance of quality guidelines that are available for adoption by all member states, particularly those outside the ICH  regions, including the developing countries. The IFPMA has collaborated with the WHO in this program and, more recently, has participated in expert briefing meetings to comment these guidelines. A key principle has been consistency with the ICH  guidelines, but providing more information and clarification for the less advanced countries.

The WHO guidelines have a specific role in supporting the Prequalification Program which aims to make quality priority medicines available for the benefit of those in needs. The list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health is used principally by United Nations agencies including UNAIDS and UNICEF to guide their procurement decisions. It has also been used by the Global Fund to Fight AIDS, Tuberculosis and Malaria and other organizations that fund supply of medicines to those in needs. Based on public heath objectives, the IFPMA has been a strong advocate of the application of the same global, unified quality standards to these charitable supplies.

To complement these guidelines, the WHO also publishes the International Pharmacopoeia (Ph. Int.), which is a collection of quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms together with supporting general methods of analysis, that is intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmaceutical requirements. The IFPMA has collaborated with the WHO in the development and maintenance of monographs, and encourages its members to cooperate with the WHO in the provision of specifications, test methods and samples to develop new monographs in line with the Ph. Int. work program.

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