Key facts

Every year, billions of US dollars worth of medicines are purchased by or through international procurement agencies – such as UNICEF, the Global Fund lớn Fight AIDS, Tuberculosis & Malaria, & UNITAID – for distribution in resource-limited countries. The Prequalification of Medicines Programme (PQP) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy. At the kết thúc of 2012, the List of Prequalified Medicinal Products contained 316 medicines for priority diseases.'s các mục of prequalified medicinal products is used by international procurement agencies và increasingly by countries khổng lồ guide bulk purchasing of medicines. PQP also prequalifies active pharmaceutical ingredients and unique control laboratories. prequalification of medicines is a service provided by khổng lồ assess the quality, safety & efficacy of medicinal products. Originally, in 2001, the focus was on medicines for treating Sida, tuberculosis & malaria. In 2006, this was extended lớn cover medicines & products for reproductive health & again in 2008, to cover prequalification of zinc, for managing adễ thương diarrhoea in children. At the end of 2012, the List of Prequalified Medicinal Products contained 316 medicines for priority diseases.

Every year, billions of US dollars worth of medicines are purchased by international procurement agencies for distribution in resource-limited countries. Prequalification is intended khổng lồ give these agencies the choice of a wide range of quality medicines for bulk purchase.

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The prequalification of medicines process: how does it work?

Prequalification consists of five sầu components.

1. Invitation

The Prequalification of Medicines Programme (PQP), other UN agencies (UNAIDS and UNICEF) and UNITAID, issue an invitation khổng lồ manufacturers to lớn submit an expression of interest (EOI) for sản phẩm evaluation. Only products included in an EOI are eligible for prequalification.

The inclusion of a medicine in an EOI is based on one or more of three criteria:

it is listed on the Model List of Essential Medicines; an application for its addition to lớn the Model List has been submitted to lớn the relevant Expert Committee for assessment, và is likely to lớn meet the criteria for inclusion (based on public health need, comparative sầu effectiveness, safety và cost-effectiveness); it is recommended for use by a current treatment guideline.

2. Dossier submission

The manufacturer provides a comprehensive sầu set of data about the quality, safety & efficacy of the sản phẩm submitted for evaluation. This includes:

data on the purity of all ingredients used in manufacture; data on the finished pharmaceutical sản phẩm (such as information about stability); results of bioequivalence tests (clinical trials conducted in healthy volunteers), unless waived.

3. Assessment

A team of assessors evaluates all the data presented. Assessment teams include staff và experts from national regulatory authorities worldwide.

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4. Inspection

A team of inspectors verifies that the manufacturing sites for the finished pharmaceutical sản phẩm và its active sầu pharmaceutical ingredient(s) comply with good manufacturing practice. They also verify that any contract research organization that conducted any clinical studies relating to lớn the submitted hàng hóa complies with good clinical practice và good laboratory practice.

5. Decision

If the product is found to lớn meet the specified requirements, & the associated manufacturing site(s) và contract retìm kiếm organization(s) are compliant with standards, the hàng hóa is added lớn the menu of prequalified medicinal products.

The prequalification of medicines process can take as little as three months, provided the data presented are complete & demonstrate that the sản phẩm meets all required standards. If data are insufficient, however, the process can take considerably longer since the manufacturer must submit the necessary data for reassessment.

To ensure that prequalified products continue to lớn meet specifications, PQPhường. regularly re-inspects manufacturing sites of prequalified products. It also evaluates any changes (known as "variations") made khổng lồ specifications, manufacturing processes & unique control of prequalified products, and conducts random unique control tests on sampled prequalified products.

Increasing the availability of quality-assured medicines

PQP bases its activities on international pharmaceutical standards for medicines chất lượng, safety and efficacy. As well as prequalifying medicines, it also prequalifies pharmaceutical quality control laboratories và active pharmaceutical ingredients, & conducts considerable advocacy for medicines of guaranteed unique. Its long-term goal is to increase the availability of quality-assured medicines by assisting manufacturers to lớn comply with standards and supporting regulatory authorities lớn implement them. It does not seek to replace national regulatory authorities or national authorization systems for importation of medicines.

Capathành phố building and technical assistance

In addition lớn evaluation & inspection activities, PQP builds national capacity for sustainable manufacturing và monitoring of chất lượng medicines, by organizing training và hands-on experience at the country-màn chơi.

It also offers a three-month rotational post at headquarters lớn national regulatory staff from developing countries. By working closely with senior Programme assessors, incumbents increase their technical expertise & enhance information exchange between their regulatory authority and PQP on their return lớn their trang chính country. Each of these activities promotes communication between stakeholders on pharmaceutical issues relating to lớn quality.

Additionally, PQPhường provides targeted technical assistance for manufacturers & quality control laboratories. Assistance is delivered by specialists are not involved in prequalification assessment or inspection activities, but can conduct audits and training at country-màn chơi. This assistance is aimed at resolving specific technical problems.

Why does run the Prequalification of Medicines Programme?

PQPhường is a United Nations programme managed by It is the only global medicines quality assurance programme. No other global toàn thân receives the active tư vấn of regulatory experts from both developed và developing countries.