PAHO’s approach to regulatory strengthening in small states, which is based on the PANDRH concept note that was presented at the PANDRH Conference in San Salvador, El Salvador, in 2018 has been published in BMJ Global Health.
The publication is available at https://gh.bmj.com/content/5/2/e001912
The draft working document on “Revision of WHO GMP for sterile pharmaceutical products – a joint EU, PIC/S, WHO project”, is for public consultation due on 20 April 2020.
Additional information available at http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/
National Regulatory Authorities (NRAs) of Argentina (ANMAT) and Brazil (ANVISA) made the first exchanges of medical devices audit reports using the Regulatory Information Secure Exchange (RISE) module.
Additional information here
Washington, D.C., 20 December 2019 (PAHO)-The National Regulatory Authorities (NRA) of Argentina (ANMAT), Colombia (INVIMA), Ecuador (ARCSA), El Salvador (DNM), Guyana (GAFDD), Mexico (COFEPRIS) and Venezuela (INHRR) have participated for the first time of the Single Medical Device Audit Program (MDSAP) Forum, held from 5-6 December 2019 in Washington D.C., USA.
For additional information please click here.
The Pan American Health Organization invites you to celebrate Universal Health Day 2019, with the theme “Universal health: everyone, everywhere” – Compact on Primary Health Care for Universal Health 2030.
The PAHO Director, Carissa F. Etienne, and representatives from the academic field, NGOs, and U.S. authorities will participate of the event. Speakers will talk about achievements and new challenges to achieve Universal Health by 2030, with reference to the Compact 30.30.30: Primary Health Care for Universal Health.
When: Thursday, 12 December 2019
Time: 10 AM (EDT)
How: www.vimeo.com/pahotv
The International Pharmaceutical Regulators provide Training Manual on the Basic of Analytical Comparability of Biosimilar Monoclonal Antibodies (English, Spanish, Russian) at http://www.iprp.global/page/biosimilar-activities
The National Regulatory Authority from Brazil, ANVISA, was elected for the last vacant position at the Management Committee of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH.
For more information in Portuguese, please click here.
Interview with Analía Ines Porrás, during the 57 Directing Council, regarding the actual situation with organ transplantation.
WHO Expert Committee on Biological Standardization (ECBS) have been posted main outcomes of the meeting held from 21 to 25 October 2019 on the biologicals website at the url as follows: https://www.who.int/biologicals/WHO_ECBS/en/
Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines; and Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) – Amendments (2019) to Annex 3 of WHO TRS No. 993
Please note that, as stated in the document, they are now subject to WHO editorial review and there will be further editorial changes but without affecting the technical contents. The final version will be published in the WHO Technical Report Series (TRS) in 2020.
The CARPHA Caribbean Regulatory System (CRS) recently recommended its first biosimilar product which can become part of the support to cancer management in its Member States. Pegfilgrastim, the active ingredient, is designed to boost the body’s immune response, thereby allowing cancer patients to keep fighting infections while receiving cancer treatments, such as chemotherapy, that harm blood cell production. It may be used in the management of various cancers.
For more information go to http://new.carpha.org/What-We-Do/Programmes-and-Projects/CRS/Caribbean-Regulatory-System
