The Essential Medicines and Health Products (EMP) Department at WHO released a draft of the WHO Global Benchmarking Tool (GBT) version VI for comment by National Regulatory Authorities at the following link: http://www.who.int/medicines/regulation/benchmarking_tool/en/ .  The GBT is a means by which WHO evaluates medicine and vaccine regulatory systems through a comprehensive and systematic benchmarking process.

The revised draft GBT is the result of a collaborative effort between WHO headquarters and the WHO Regional Office for the Americas (PAHO/AMRO) with contributions from other Regional Offices and experts from national regulatory authorities. The tool builds on previous WHO NRA benchmarking tools and includes features of proven benefit such as computerization, categorization of indicators/sub-indicators and inclusion of fact sheets.

GBT draft version VI is open for comment until 28 February 2018. All comments should be sent to Dr Alireza Khadem, Scientist, Regulatory System Strengthening (RSS) team (khadembroojerdia@who.int) using the comments table available under the related links section. The draft tool is presented as consolidated indicators and fact sheets organized by regulatory function, together with a list of references and terminology used in the WHO GBT.

The 18^th International Conference of Drug Regulatory Authorities (ICDRA) is now up and running. Please see the link: http://www.icdra2018.ie/ which contains all necessary information about the Conference as well as the registration module.

The theme of the conference is: Smart Safety surveillance: A life-cycle approach to promoting safety of medical products.

The 18th ICDRA will facilitate focused discussions on quality issues, regulatory reform and strengthening regulatory systems, safety of medical products, substandard and falsified products, access, regulation of clinical trials, regulatory collaboration, harmonization, convergence and reliance, new technologies, regulation of herbal medicines, etc. It will be held in Dublin, Ireland, on  3 – 7 September 2018.

[Source in Spanish]

2018 will be a year of challenges and opportunities in terms of health regulation. COFEPRIS will promote a responsible regulatory policy that guarantees the access of Mexicans to more and better health solutions. Actions in clinical research, medical devices, innovative medicines, generics and biotechnology will be strengthened, and work will be done to reduce the gap in scientific knowledge https://www.gob.mx/cofepris/prensa/mexico-inicia-2018-como-integrante-formal-de-pic-s

Source: https://www.gob.mx/cofepris/articulos/mexico-inicia-2018-como-integrante-formal-de-pic-s-142121?idiom=es

[Source in Spanish]

As part of the official visit to Cuba of the President of Chile Michelle Bachelet and the delegation that accompanies it, a seminar “Trade and Investment Perspectives: Chile-Cuba” took place yesterday, the delegation formed by the Minister of Economy Jorge Rodríguez, the Vice Minister of Commerce of the Ministry of Foreign Affairs of Chile Paulina Nazal Aranda, the Director (S) of the Institute of Public Health of Chile (ISP) Pablo Ortíz and the Head of the Subdepartment of Registration and Health Authorizations of the ISP Patricia Carmona . In addition, representatives of the investment sector and the pharmaceutical area of Chile, as well as rectors of the most important universities in Chile.

For more information go to http://www.cecmed.cu/content/cecmed-en-seminario-perspectivas-del-comercio-e-inversiones-chile-cuba 

[Original text in Spanish]

Desde el lunes 4 y hasta el jueves 7 de diciembre, en el marco de un proyecto de cooperación institucional con el ISP, técnicos chilenos trabajaron en conjunto con funcionarios de la DNVS en el fortalecimiento institucional, dando varias presentaciones, consejo profesional e intercambio de experiencias relevantes con el equipo institucional y también reuniones en el Gabinete del Ministro de Salud y en la Organización Panamericana de la Salud.

Estas actividades conjuntas se encuentran en el marco del Plan de Desarrollo Institucional (PDI) de la DNVS y tuvo el objetivo de asesorar en las siguientes áreas: a) Sistema regulador, b) Registro, Licenciamiento de Productores, c) Inspecciones, d) Laboratorio Oficial de Medicamentos, y e) Liberación de lotes de vacunas.

Fuente:

https://www.mspbs.gov.py/dnvs/13848/expertos-del-instituto-de-salud-publica-de-chile-hacen-visita-de-cooperacion-tecnica-en-la-dnvs.html

Health sector stakeholders were, this morning, briefed on the importance of having safe and quality pharmaceutical drugs on the local market.

The workshop was held at Duke Lodge and sought to utilise the professional standards of the Caribbean Regulatory System to strengthen the function and regulatory capacity in Guyana.

Government Analyst Food and Drug Department (GA-FDD) Director Marlan Cole noted that even though Guyana has stringent measures in procuring drugs, the government recognises the challenges it faces in the registration of quality pharmaceutical drugs, locally.

According to the Food and Drug Director, it is critical to ensure that “those who are responsible for procurement, those who are responsible for drugs at the Georgetown Public Hospital were invited to ensure that they are sensitised as it relates to the requirements, the support, the functions and capacity of the CRS.”

For more information go to http://gina.gov.gy/guyana-to-adopt-crs-measures-for-procurement-of-pharmaceuticals/  

The Caribbean Regulatory System (CRS)