Prequalification Là Gì

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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 and Malaria, & UNITAID – for distribution in resource-limited countries.The onaga.vn Prequalification of Medicines Programme (PQP) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety & efficacy.At the over of 2012, the onaga.vn menu of Prequalified Medicinal Products contained 316 medicines for priority diseases.onaga.vn's các mục of prequalified medicinal products is used by international procurement agencies & increasingly by countries to lớn guide bulk purchasing of medicines.PQP also prequalifies active pharmaceutical ingredients and unique control laboratories.

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onaga.vn prequalification of medicines is a service provided by onaga.vn to assess the quality, safety & efficacy of medicinal products. Originally, in 2001, the focus was on medicines for treating HIV/AIDS, tuberculosis & malaria. In 2006, this was extended to cover medicines and products for reproductive health and again in 2008, khổng lồ cover prequalification of zinc, for managing acute diarrhoea in children. At the over of 2012, the onaga.vn các mục 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.

The onaga.vn prequalification of medicines process: how does it work?

Prequalification consists of five components.

1. Invitation

The onaga.vn Prequalification of Medicines Programme (PQP), other UN agencies (UNAIDS and UNICEF) & 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.

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

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

2. Dossier submission

The manufacturer provides a comprehensive phối of data about the quality, safety and 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 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 onaga.vn staff và experts from national regulatory authorities worldwide.

4. Inspection

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

5. Decision

If the sản phẩm is found to lớn meet the specified requirements, & the associated manufacturing site(s) và contract research organization(s) are compliant with onaga.vn standards, the product is added lớn the onaga.vn danh sách of prequalified medicinal products.

The onaga.vn 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 meet onaga.vn specifications, PQP regularly re-inspects manufacturing sites of prequalified products. It also evaluates any changes (known as "variations") made khổng lồ specifications, manufacturing processes and chất lượng control of prequalified products, và conducts random quality control tests on sampled prequalified products.

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Increasing the availability of quality-assured medicines

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

Capacity building và technical assistance

In addition to lớn evaluation và inspection activities, PQP builds national capacity for sustainable manufacturing and monitoring of unique medicines, by organizing training và hands-on experience at the country-level.

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

Additionally, PQP provides targeted technical assistance for manufacturers and chất lượng control laboratories. Assistance is delivered by specialists onaga.vn are not involved in onaga.vn prequalification assessment or inspection activities, but onaga.vn can conduct audits and training at country-level. This assistance is aimed at resolving specific technical problems.

Why does onaga.vn run the Prequalification of Medicines Programme?

PQP is a United Nations programme managed by onaga.vn. It is the only global medicines quality assurance programme. No other global body toàn thân receives the active support of regulatory experts from both developed và developing countries.