Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers.

A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes (PACs), reveals significant variability and lack of predictability of timelines for regulatory review and approval. These shortcomings imply that multiple data packages have to be prepared for submission to different authorities, generating a complex regulatory environment. Moreover, the timelines for approval by individual national regulatory authorities are variable, which results in manufacturers keeping various stocks of vaccines produced in accordance with the various approved specifications and procedures, in the different countries. This can seriously affect timely availability of vaccine in those countries. The World Health Organization (WHO) guidelines on procedures and data requirements for changes to approved vaccines provide a consensual framework for alignment, but are still underused. Reliance on both the review and approval by the regulatory authority in the country of manufacturing, or on the review performed by other national regulatory authorities, recognized by WHO as stringent, or on WHO prequalification dossier, offer alternative ways forward. These and other options to improve the management of post-approval changes during the product lifecycle of vaccines are discussed in this report, and aimed at improving guidelines alignment and regulatory convergence to advance immunization equity and coverage.

Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures: An industry perspective.

Vaccines play an essential role in preventing infectious diseases. Their registration in importing countries is often cumbersome and unpredictably lengthy, leading to delays in vaccine access for populations that need them most. This report builds on a previous publication identifying challenges for registration of vaccines in emerging countries. As a matter of social responsibility, it was judged necessary to address the challenges and offer a set of solutions for open dialogue. Based on regular exchange of information and experiences, a group of regulatory experts from the vaccine industry developed three sets of proposals for consideration by vaccine stakeholders, with a view to improving the situation, by fostering regulatory convergence, with viable options for streamlining registration procedures through reliance on other experienced regulators or international agencies. Further, it offers options for alignment of structure and contents of Common Technical Document modules and presents a harmonized template application form that could potentially be used by all countries.

Joint evaluation of marketing authorization files of inactivated polio vaccines in countries of the Eastern Mediterranean Region.

BACKGROUND: In 2012, the World Health Assembly declared ending polio a "programmatic emergency for global public health". In response, the Global Polio Eradication Initiative developed "The Polio Eradication and Endgame Strategic Plan 2013-2018" to address the eradication of all types of poliomyelitis. AIMS: The World Health Organization invited selected countries in the Eastern Mediterranean Region to take part in a joint evaluation of the marketing authorization files of candidate standalone inactivated poliovirus vaccines (IPVs), aimed to facilitate the evaluation process and expedite the timelines for registration. METHODS: This report describes the planning, organization and execution of the joint meeting among 6 countries of Eastern Mediterranean Region. RESULTS: Participants prepared a joint list of questions and concerns which was shared and discussed with the respective manufacturers on the last day of the review. Manufacturer provided answers to the questions. The questions that could not be responded to immediately by the manufacturer remained to be addressed after the meeting directly between the manufacturer and the national regulatory authoritys. A final joint evaluation report was prepared before the end of the meeting by the participating countries. CONCLUSIONS: The report focuses on the benefits of the exercise and highlights its shortcomings as a sole strategy to secure the timely registration of the vaccine in target countries. We discuss additional aspects to be addressed to effectively accelerate registration, and hence access to priority vaccines.

Mejora de la seguridad, calidad y eficacia de los medicamentos en la Región de las Américas

En la Región de las Américas, el acceso a los medicamentos y otras tecnologías sanitarias constituye una prioridad para los países en su avance hacia el acceso universal a la salud y la cobertura universal de salud. Es necesario asegurar la disponibilidad de medicamentos y tecnologías sanitarias asequibles dentro de los servicios de salud como parte del abordaje integral de la prevención y el control de las enfermedades. Mediante la adopción de políticas y estrategias farmacéuticas a nivel nacional, los gobiernos establecen el marco que garantizará el acceso equitativo y la asequibilidad de los medicamentos y las tecnologías sanitarias, al tiempo que promueve su uso racional. El principio de calidad, seguridad y eficacia ocupa un papel central en tales políticas y estrategias. El sector farmacéutico y de la tecnología sanitaria desempeña una función crucial en la promoción y protección de la salud al asegurar que los productos y tecnologías que se ponen a disposición de las personas por intermedio de los sistemas de salud respondan a las normas internacionales de calidad y seguridad. La función del gobierno y en particular del ministerio de salud, conjuntamente con los interesados directos, es crear un entorno de regulación que garantice la calidad del producto a lo largo de toda su vida útil, garantizar la seguridad para el paciente y optimizar los resultados en materia de salud...