Regulatory convergence and harmonization: barriers to effective use and adoption of common standards.
Rev Panam Salud Publica
; 39(5): 217-225, 2016 May.
Article
en En
| MEDLINE
| ID: mdl-27706409
ABSTRACT
Objective To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Methods An in-depth analysis of the incorporation of PANDRH Technical Document No. 1 ("TDNo1") recommendations in member states' national requirements was carried out. Results The results illustrate the role of PANDRH in promoting convergence/harmonization among its members. Conclusions The study results show that the rate of use of TDs varied greatly by product/area and country. Timing, TD content, and product/area, and, more importantly, national capacities, are critical determinants of the level of TD guideline adoption. While PANDRH TDs have proven instrumental for the harmonization/convergence of member states' national requirements, as shown by the level of convergence across a majority of the national requirements issued for vaccine licensing, several countries had yet to incorporate common standards due, in large part, to weak national regulatory capacities. Therefore, harmonization/convergence initiatives should include the strengthening of national regulatory capacities as part of their core strategy, which will, in turn, allow for the incorporation and deployment of common standards in all participating countries.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vacunas
/
Adhesión a Directriz
/
Legislación de Medicamentos
Tipo de estudio:
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Rev Panam Salud Publica
Asunto de la revista:
SAUDE PUBLICA
Año:
2016
Tipo del documento:
Article