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Markster con dr who registration#

training (for manufacturers, regulators and QCLs).

Other medicines prequalification activities include: The standards used to evaluate FPPs and APIs, and their manufacturing sites, are based on the principles and practices agreed by the world’s leading regulatory agencies and adopted by the WHO Expert Committee on Specification for Pharmaceutical Preparations. WHO also prequalifies quality control laboratories (QCLs), specifically those QCLs that carry out chemical and microbiological testing of medicines.

organization of quality control testing of products.

inspection of manufacturing and clinical sites.

assessment of product dossiers (for finished pharmaceutical products (FPPs) or master files (for active pharmaceutical ingredients (APIs).

Medicines key prequalification activities are: The efforts of each of these stakeholders is essential to increasing universal health coverage, protecting people from health emergencies and providing people with better health and well-being. Perhaps most importantly, it has demonstrated and continues to demonstrate that the production, supply and regulation of quality-assured medicines is a shared endeavour between regulators, manufacturers, procurers, health providers, donors and WHO. Indeed, medicines prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines. Problems with the quality of medicines and their supply led to the creation of WHO medicines prequalification in 2001. From a public health perspective, the greatest achievement of medicines prequalification has been to improve the quality of life-saving medicines used today by millions of people in low- and middle-income countries.

Pilot prequalification procedure: overview.

Abridged assessment – APIMF accepted previously by an authority applying stringent standards.

Abridged assessment – APIMF assessed previously using APIMF procedure.

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Full assessment – APIMF not previously assessed.SRA-approved multisource (generic) or innovator FPPs.Full assessment – multisource (generic) FPPs.Benefits of WHO medicines prequalification.WHO Public Inspection Reports (WHOPIRs).List of Prequalified Vector Control Products.About Vector Control Products Prequalification.Vaccine information by disease category.Prequalified vaccine annual report (PQVAR).Vaccines Eligible for WHO Prequalification.Support to Manufacturers, CROs and QCLs.Pilot Prequalification of Biotherapeutic Products.WHO medicines prequalification guidance.

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Accelerated registration of FPPs approved by SRAs.Accelerated registration of prequalified FPPs.Collaborative Procedures for Accelerated Registration.Post-prequalification Procedures & Fees: APIs, FPPs, QCLs.Prequalification Procedures & Fees: FPPs, APIs & QCLs.FPPs and APIs Eligible for Prequalification ('EOIs').Collaborative Procedure for Accelerated Registration.Post-prequalification Procedures: Prequalified MCDs.

Post-prequalification Procedures & Fees: Prequalified IVDs.

Prequalification Procedures & Fees: MCDs.

Prequalification Procedures & Fees: IVDs.

About In Vitro Diagnostic & Male Circumcision Device Prequalification.

Prequalification guidance for manufacturers.

Post-prequalification Procedures & Fees.

Laboratory Accreditation for Product Testing.

Product Testing Support for Manufacturers.

WHO Catalogue of Prequalified Immunization Devices.

About Immunization Devices Prequalification.