Cargando…

Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice

BACKGROUND: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis. However, the CPP format, issu...

Descripción completa

Detalles Bibliográficos
Autores principales: Rodier, Céline, Bujar, Magda, McAuslane, Neil, Patel, Prisha, Liberti, Lawrence
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785566/
https://www.ncbi.nlm.nih.gov/pubmed/32617911
http://dx.doi.org/10.1007/s43441-020-00196-2
_version_ 1783632471384915968
author Rodier, Céline
Bujar, Magda
McAuslane, Neil
Patel, Prisha
Liberti, Lawrence
author_facet Rodier, Céline
Bujar, Magda
McAuslane, Neil
Patel, Prisha
Liberti, Lawrence
author_sort Rodier, Céline
collection PubMed
description BACKGROUND: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis. However, the CPP format, issuing process and use have not been revised since 1997 and there are significant differences among countries in regard to requirements for CPP timing, terminology, and format. We sought to determine current CPP practices versus national regulatory guidelines and to inform recommendations for the efficient use of the CPP based on the needs of the modern regulatory environment. METHODS: We conducted a comparative analysis of company practice versus agency guidelines across 18 maturing pharmaceutical markets using data from the Cortellis for Regulatory Intelligence® (CRI) and the Centre for Innovation in Regulatory Science (CIRS) Emerging Markets Regulatory Review Times (EMaRReT) databases and regulatory authorities’ websites. RESULTS: Of the studied 18 countries, 16 require the CPP for submission of new registrations; many accept alternative documentation but most still require legalization of the CPP and many are not compliant with the complex CPP format. Additional complicating factors include language requirements and varying local guidelines for CPP submission timing and validity dates. CONCLUSIONS: With the implementation of a number of suggested improvements, the CPP can continue to serve an important role in streamlining regulatory efficiency and provide confidence in new medicines, ensuring a more efficient and effective approval process and expediting patient access to safe and effective medicines worldwide.
format Online
Article
Text
id pubmed-7785566
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-77855662021-01-11 Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice Rodier, Céline Bujar, Magda McAuslane, Neil Patel, Prisha Liberti, Lawrence Ther Innov Regul Sci Original Research BACKGROUND: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis. However, the CPP format, issuing process and use have not been revised since 1997 and there are significant differences among countries in regard to requirements for CPP timing, terminology, and format. We sought to determine current CPP practices versus national regulatory guidelines and to inform recommendations for the efficient use of the CPP based on the needs of the modern regulatory environment. METHODS: We conducted a comparative analysis of company practice versus agency guidelines across 18 maturing pharmaceutical markets using data from the Cortellis for Regulatory Intelligence® (CRI) and the Centre for Innovation in Regulatory Science (CIRS) Emerging Markets Regulatory Review Times (EMaRReT) databases and regulatory authorities’ websites. RESULTS: Of the studied 18 countries, 16 require the CPP for submission of new registrations; many accept alternative documentation but most still require legalization of the CPP and many are not compliant with the complex CPP format. Additional complicating factors include language requirements and varying local guidelines for CPP submission timing and validity dates. CONCLUSIONS: With the implementation of a number of suggested improvements, the CPP can continue to serve an important role in streamlining regulatory efficiency and provide confidence in new medicines, ensuring a more efficient and effective approval process and expediting patient access to safe and effective medicines worldwide. Springer International Publishing 2020-07-02 2021 /pmc/articles/PMC7785566/ /pubmed/32617911 http://dx.doi.org/10.1007/s43441-020-00196-2 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Research
Rodier, Céline
Bujar, Magda
McAuslane, Neil
Patel, Prisha
Liberti, Lawrence
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
title Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
title_full Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
title_fullStr Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
title_full_unstemmed Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
title_short Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
title_sort use of the certificate for pharmaceutical products (cpp) in 18 maturing pharmaceutical markets: comparing agency guidelines with company practice
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785566/
https://www.ncbi.nlm.nih.gov/pubmed/32617911
http://dx.doi.org/10.1007/s43441-020-00196-2
work_keys_str_mv AT rodierceline useofthecertificateforpharmaceuticalproductscppin18maturingpharmaceuticalmarketscomparingagencyguidelineswithcompanypractice
AT bujarmagda useofthecertificateforpharmaceuticalproductscppin18maturingpharmaceuticalmarketscomparingagencyguidelineswithcompanypractice
AT mcauslaneneil useofthecertificateforpharmaceuticalproductscppin18maturingpharmaceuticalmarketscomparingagencyguidelineswithcompanypractice
AT patelprisha useofthecertificateforpharmaceuticalproductscppin18maturingpharmaceuticalmarketscomparingagencyguidelineswithcompanypractice
AT libertilawrence useofthecertificateforpharmaceuticalproductscppin18maturingpharmaceuticalmarketscomparingagencyguidelineswithcompanypractice