[Original text in spanish]

The subjects of interest on the part of the Ministry of Health of Panama (MINSA) are focused on the regulation of importation of medicines, the process of issuing the marketing authorization (medicines registry), post-marketing analysis controls, and detection of counterfeit or fraudulent medicines, among other topics will be prioritized during 2018 by Invima.

For more information go to  https://www.invima.gov.co/invima-comparte-con-minsalud-de-panam%C3%A1-su-experiencia-exitosa-regulaci%C3%B3n-de-medicamentos.html

Paraguay have become the 128th member of the WHO Programme for International Drug Monitoring!

Currently, 129 countries are full members of the WHO Programme for International Drug Monitoring.

For more information about the Uppsala Monitoring Center go to https://www.who-umc.org/

Source: https://www.linkedin.com/feed/update/urn:li:activity:6359396252232273920

Monday, January 15, 2018

With the objective of strengthening the supervision of generic medicines to be of quality, safe and accessible to the population, the Minister of Health, Dr. Abel Salinas Rivas, announced that the general direction of medicines of the Ministry of Health (Minsa) will become a powerful body to regulate the pharmaceutical industry.

For more information go to http://www.minsa.gob.pe/index.asp?op=51&nota=25828

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