Collaborative Procedure in the Assessment and Accelerated National Registration of Pharmaceutical Products and Vaccines Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 1010, 2018, Annex 11
(2018; 54 pages)

Resumen

Management of diseases known to be of major relevance to public health in countries with limited regulatory resources is often jeopardized by delayed access to new or needed therapies. Although many medicines successfully pass a regulatory review process conducted by internationally respected regulatory bodies, also known as stringent regulatory authorities (reference SRAs), or may in addition have been prequalified by the World Health Organization (WHO), local regulatory approvals tend to consume additional time and resources of national regulatory authorities (NRAs) before these therapies can be made available to patients.

To address this issue, WHO proposes a scheme for NRAs and pharmaceutical manufacturers to facilitate registrations of the vaccines and pharmaceutical products, including biotherapeutic products approved by reference SRAs. WHO recognizes the scientific evaluation of medicines by reference SRAs as they apply similarly stringent standards for quality, safety and efficacy to those recommended by WHO.

Based on WHO experience with the Collaborative procedure of WHO prequalified pharmaceutical products and vaccines, it is possible to facilitate and accelerate national registration processes by provision of detailed assessment and inspection outcomes generated by respected regulatory bodies. Assessment and inspection reports of reference SRAs made available in addition to the registration dossiers can facilitate the adoption of national regulatory decisions by assuring NRAs about the positive risk–benefit profile of a product and that its quality is identical with the product already approved elsewhere. Normally, publicly available versions of assessment and inspection outcomes do not provide all the necessary information in sufficient detail to enable regulatory decisions to be adopted. Therefore, detailed assessment and inspection outcomes that include commercially sensitive data must be shared. Whether to make such information sharing possible is up to interested pharmaceutical manufacturers, which should provide consent to information exchange among reference SRAs and NRAs, to which a product is submitted for regulatory approval. Pharmaceutical manufacturers benefit from accelerated and facilitated regulatory processes. For their part, it is up to interested NRAs to provide sufficient assurance that shared data will be treated with necessary care and respect for confidentiality. Nonetheless, in some jurisdictions, publicly available information such as public assessment or inspection reports, and databases of compliance with good manufacturing practices (GMP) contain substantial summarized regulatory information that can facilitate the decision-making process in less well-resourced NRAs as well.

It should be stressed that the decision to apply the process for specific medicines is up to the NRAs concerned, which retain the prerogative to conclude their assessment through sovereign decisions on medicine registration within their national jurisdiction.

In addition to the facilitation of regulatory decisions on needed medicines and faster access to patients, the process also represents an avenue for harmonization of regulatory requirements and capacity-building.

The Procedure is applicable in principle to all types of medicines irrespective of whether the products are of an innovative or generic nature. The procedure is also applicable to biotherapeutic products and vaccines.

 
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