The document on Good Regulatory Practices for regulatory oversight of medical products is under public consultation due on 11 September 2020.
Please send your comments to Marie Valentin (valentinm@who.int) and Carolyn Doucelin (doucelinc@who.int).
Further information: https://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
The draft document on Policy on Evaluating and publicly designating regulatory authorities as WHO listed authorities is under public consultation until 15 September 2020.
Please send your comments to Mohamed Refaat (refaatm@who.int) e Yvonne Melounou (melounouy@who.int).
Additional information: https://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
The draft document on Good Reliance Practices in regulatory decision-making for medical products: high level principles and considerations is under public consultation.
Please send your comments to Marie Valentin (valentinm@who.int) and Carolyn Doucelin (doucelinc@who.int) no later than 18 September 2020.
Further information:
https://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
The draft document on Recommendations to assure the quality, safety and efficacy of typhoid conjugate vaccines is under public consultation. Comments should be sent to Richard Isbrucker (isbruckerr@who.int) no later than 18 September 2020.
Further information: https://www.who.int/news-room/articles-detail/call-for-comments-on-tcv-guidelines-posted-on-who-biologicals-website
The draft document on WHO Recommendation to assure the quality, safety and efficacy of enterovirus 71 vaccines (inactivated) is under public consultation.
Please send your comments to leid@who.int no later than 2 October 2020.
additional information: https://www.who.int/news-room/articles-detail/who-bs-2020.2388-recommendations-to-assure-the-quality-safety-and-efficacy-of-enterovirus-71-vaccines-(inactivated)
As of August 11, the opinions issued by ANVISA in the marketing authorization process are available on the Consultations link on the Anvisa portal (https://consultas.anvisa.gov.br/#/pareceres/). The document called Public Opinion on Medicinal Evaluation (PPAM, in Portuguese) provides a summary of the technical evaluation, including the reason that led to the approval or disapproval of the registration of a medicine.
According to ANVISA, the essence of the consultation did not change, it was only migrated to a more modern and more agile platform. Thus, it continues to allow searching by name of the drug, active ingredient, category of the drug, type of decision, company and date. In the results, in addition to the evaluation opinion, interested parties will also be able to find information about the medications, such as registered presentations, manufacturing location, use restriction, package insert, among other information.
Additional information here
ANVISA has issued a report that highlights the Agency´s actions on fighting COVID-19 pandemics.
Such report is available at https://sway.office.com/s/KiGUIHh31qAKhdVF/embed
The project titled “Assessing Certificate of Pharmaceutical Prodcut (CPP) requirements for drug registration processes in the Region of the Americas towards more timely access to medicines and more convergent regulatory approaches” was the first project approved by the Pan American Network for Drug Regulatory Harmonization (PANDRH) Steering Committee to be jointly conducted by a NRA and a pharmaceutical industry association, CECMED (Cuba) and FIFARMA, respectively.
Its preliminary results were presented during the 2020 DIA Global Conference in June, including information of 27 countries of the Americas. The final report is expected for the upcoming months, which will contribute to the ongoing international discussions for the revision of the Certification Scheme on the quality of pharmaceutical products moving in international commerce.
The development of the CPP Project in PANDRH was initially proposed by FIFARMA and promptly sponsored by CECMED. The work and dedication of the Cuban NRA to the Project have been instrumental for the results achieved so far. This level of engagement was only possible because of the endorsement and outstanding collaboration offered by CECMED’s former Director, Dr Rafael Pérez Cristiá, who greatly contributed to global health work, advancing regulatory strengthening and fostering regional cooperation among NRAs in the Region.
Further information at:
https://www.cecmed.cu/avisos/curso-proyecto-red-parf-coordinado-cecmed-fifarma
https://fifarma.org/en/cecmed-fifarma-project-presented-in-the-2020-dia-global-conference/
The Caribbean Public Health Agency’s Caribbean Regulatory System (CARPHA – CRS) has issued a recommendation of a diagnostic test kit for the novel SARS-CoV-2 coronavirus 2019 for emergency use authorization and/or import by the Member States of the Caribbean Community (CARICOM). The agency has implemented a verification review process for medicines, vaccines and test kits, that were approved for emergency use by recognized regulatory authorities, according to a PAHO document “Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)” that provides guidance to national regulatory authorities and regulatory systems on practical ways to implement reliance for emergency use of medicines and other health technologies in and around a pandemic.
To date, more than 100 medicines and other health technologies has been ercommended by CARPHA-CRS to CARICOM Member States. Such recommendations are based on verification that the same products have been approved in reference agencies. Over 20 different companies have submitted products, which are typically generic versions of essential medicines, including products for non-communicable diseases like hypertension and cancer. The CARPHA-CRS has recommended innovator products as well, including a product that is curative for Hepatitis C, which was recently registered in Jamaica.
Further information available at:
CRS recommended medicines list
The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program created by the FDA. It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.
The FDA continues to support clinical trials that are testing new treatments for COVID-19 to gain valuable knowledge about their safety and effectiveness.
Further information at: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
