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.paho.org/hq/index.php?option=com_content&view=article&id=11826:trabajo-tecnico-redparf-grupos&Itemid=41777&lang=en

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:

https://carpha.org/More/Media/Articles/ArticleID/343/CARPHA%E2%80%99s-Caribbean-Regulatory-System-CRS-Recommends-Its-First-COVID-19-PCR-Test-Kit-for-Pandemic-Use-to-CARICOM

CRS recommended medicines list

Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19)

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

Attention: 

The FDA is advising consumers not to use hand sanitizer products manufactured by Eskbiochen due to the potential presence of methanol, a substance that can be toxic when absorbed through the skin or ingested.

Further information: https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-hand-sanitizer-products-manufactured-eskbiochem

The WHO/BS/2020.2381-  Amendment to WHO Guidelines for the safe production and quality control of poliomyelitis vaccine (Annex 4, WHO TRS No. 1016) is available at WHO biological website (http://www.who.int/biologicals/en/, right-hand) .

This document has been prepared based on the discussions at the 4^th CAG meeting in July 2019 and the WHO ECBS meeting in Oct 2019; it has taken into consideration comments received from the 1^st round Public Consultation on WHO website during February-April this year.  This version has gone through 1^st WHO editorial review and has been submitted as BS document for review by the upcoming ECBS meeting in late August.

This draft is being published to get feedback from public audience including regulatory authorities, manufacturers, and other stakeholders. Comments to be received during this round Public Consultation will be reviewed by the drafting group and presented to ECBS subsequently.

DEADLINE for submission of comments: 3 August 2020. Send your comments to Dr Tiequn Zhou at: zhout@who.int using the form available at https://www.who.int/biologicals/Comment_Form_POLIO_2_June_2020.doc?ua=1 

Further information: https://www.who.int/biologicals/POLIO_WHO_Amendments_Annex_4_TRS1016_1_JUNE_20.pdf?ua=1.

WHO has a public consultation on the following document for the WHO Expert Committee on Biological Standardization (ECBS) is now open.

WHO assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs)

The 1st draft of the Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs) has been prepared to enhance timely access to WHO-prequalified products in countries, to ensure that the product in countries is the same as the one which is WHO-prequalified and to provide a model for regulatory information exchange between countries. The draft document has been updated based on the informal consultation with experts from the National Regulatory Authorities which was conducted in November 2019 during the WHO Workshop on Collaborative Registration Procedure for Diagnostics.

WHO are now publishing this draft to get the feedback from a broad audience of relevant government authorities, manufacturers, and other experts. DEADLINE for submission of comment: 15 July 2020. Please send comments to: gunlud@who.int. 

You could download the document directly by clicking on the following link: https://www.who.int/biologicals/Collaborative_Procedure_for_IVDs_for_PC.pdf?ua=1

In order to provide your comments, please use the template, https://www.who.int/biologicals/Comment_Form_CRP_diagnostics_June_2020.doc?ua=1

Recently, regulatory entities in the Caribbean have moved to implement the PAHO recommended procedure reliance for Emergency Use Authorization in the COVID-19 pandemic (https://iris.paho.org/handle/10665.2/52027)

The National Regulatory Authority of Guyana (Government Analyst, Food and Drug Department) and the Caribbean Public Health Agency/ Caribbean Regulatory System, have both taken decisions to adopt the procedure for drugs, vaccines, and test kits.

These are important developments for many reasons. Medicines and other health technologies are available (test kits) now, or will potentially become available in the coming months, and it will be important that countries have the tools in place to properly make decisions on authorization in an expeditious manner, while based on a trusted regulator’s best scientific and regulatory judgment.

Additional information: https://carpha.org/What-We-Do/CRS/Operational-Policy and https://www.paho.org/en/news/30-4-2020-new-guideline-use-reliance-emergency-use-authorization-medicines-and-other.