Prequalification Là Gì


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 to 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 unique, safety và efficacy. At the over of 2012, the List of Prequalified Medicinal Products contained 316 medicines for priority diseases.'s menu of prequalified medicinal products is used by international procurement agencies and increasingly by countries khổng lồ guide bulk purchasing of medicines. PQPhường also prequalifies active pharmaceutical ingredients và quality control laboratories. prequalification of medicines is a service provided by to assess the quality, safety and efficacy of medicinal products. Originally, in 2001, the focus was on medicines for treating human immunodeficiency virus, tuberculosis và malaria. In 2006, this was extended to lớn cover medicines & products for reproductive sầu health and again in 2008, khổng lồ cover prequalification of zinc, for managing adễ thương diarrhoea in children. At the kết thúc 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 sầu these agencies the choice of a wide range of unique medicines for bulk purchase.

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The prequalification of medicines process: how does it work?

Prequalification consists of five components.

1. Invitation

The Prequalification of Medicines Programme (PQP), other UN agencies (UNAIDS & UNICEF) and UNITAID, issue an invitation lớn manufacturers khổng lồ submit an expression of interest (EOI) for product 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 lớn the relevant Expert Committee for assessment, and is likely khổng lồ meet the criteria for inclusion (based on public health need, comparative effectiveness, safety và cost-effectiveness); it is recommended for use by a current treatment guideline.

2. Dossier submission

The manufacturer provides a comprehensive mix of data about the chất lượng, safety and efficacy of the product submitted for evaluation. This includes:

data on the purity of all ingredients used in manufacture; data on the finished pharmaceutical product (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 and 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 product & its active pharmaceutical ingredient(s) comply with good manufacturing practice. They also verify that any contract retìm kiếm organization that conducted any clinical studies relating khổng lồ the submitted hàng hóa complies with good clinical practice and good laboratory practice.

5. Decision

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

The prequalification of medicines process can take as little as three months, provided the data presented are complete và demonstrate that the product 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 meet specifications, PQPhường regularly re-inspects manufacturing sites of prequalified products. It also evaluates any changes (known as "variations") made to lớn specifications, manufacturing processes and chất lượng control of prequalified products, and conducts random chất lượng control tests on sampled prequalified products.

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Increasing the availability of quality-assured medicines

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

Capathành phố building and technical assistance

In addition to lớn evaluation and inspection activities, PQPhường builds national capathành phố for sustainable manufacturing and monitoring of chất lượng medicines, by organizing training và hands-on experience at the country-cấp độ.

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

Additionally, PQP provides targeted technical assistance for manufacturers & chất lượng control laboratories. Assistance is delivered by specialists are not involved in prequalification assessment or inspection activities, but can conduct audits and training at country-level. 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 chất lượng assurance programme. No other global body receives the active sầu support of regulatory experts from both developed and developing countries.