Fernanda Lessa - 11:37, 10 de November de 20203,104
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In March 2020, the European Medicines Agency (EMA) informed that it would no longer provide printed Certificates of Pharmaceutical Products (CPP) but only electronically signed and authenticated ones, that would enable EMA to continue to be able provide certificates during the COVID-19 pandemic. The Agency considers electronic CPPs as the permanent way of issuing certificates.
EMA published a guidance on the format and safety features of the electronic certificates, as well on as measures to help regulatory authorities of importing countries confirm their validity. It also produced an official letter with information that might be useful for regulators when handling the electronic certificates.
On the use of electronic CPPs, WHO agrees with this initiative, which does not contradict the current guidelines. The Organization recommends other regulators issuing certificates consider this approach too, and urges regulators receiving certificates to accept the electronic signature.
Fernanda Lessa - 11:18, 2 de November de 20201,677
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The WHO has published the draft “COVID-19 Vaccines: Safety Surveillance Manual” for public consultation. Comments and suggestions shall be sent to lamprianous@who.int, no later than 13 November 2020, 12 PM CET.
This COVID-19 vaccine safety surveillance manual has been developed upon recommendation and guidance of Global Advisory Committee on Vaccine Safety (GACVS) members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
Such manual provides relevant guidance prior to, during and after COVID-19 vaccine introduction for governments, global, regional and national staff from immunization programmes, regulatory authorities, partners and pharmacovigilance centers as well as marketing authorization holders.
Work to develop a COVID-19 vaccine is faster than ever but safety and efficacy processes remain unchanged, PAHO Director says
However, while spikes in cases continue in the Region, countries must ensure a sustained response until a vaccine arrives.
Washington D.C., October 21, 2020 (PAHO) – While the Americas urgently awaits a breakthrough, the Pan American Health Organization (PAHO) will only support the distribution of a vaccine that has proven to be safe and effective in clinical trials, reviewed by National Regulatory Authorities and recommended by the World Health Organization (WHO), PAHODirector Carissa F Etienne, said today.
“It is important to emphasize that while we’re working to develop a vaccine faster than ever before, the process to guarantee its safety and efficacy is unchanged,” Etienne told a press briefing in Washington, DC. She noted that there is a pipeline of more than 180 vaccine candidates under study, with 11 in phase III clinical trials.
What has changed “is the unprecedented attention on the vaccine development process,” she added, highlighting the “over-abundance of information from a number of sources, some less reliable than others and not based on science, which has led to confusion and misinformation around vaccine safety.”
The PAHO Director emphasized that vaccines are designed and manufactured with safety in mind. Once a COVID-19 vaccine proves safe and effective in a clinical trial, regulatory agencies thoroughly evaluate the data prior to granting approvals and WHO will also oversee an independent review process before granting its own recommendation.
“How we communicate about COVID-19 will make our ability to control the pandemic,” she said, calling for countries, the media, regulatory authorities, the private sector and the scientific community to come together to provide the public with “clear, concise and science-based information about a future COVID-19 vaccine.”
Access to vaccines
An important factor to establish trust in the new vaccines is to ensure their accessibility to all countries, and PAHO is supporting countries to gain access to these vaccines through the COVAX facility, Etienne noted.
“Virtually every country in Latin America and the Caribbean has joined or is in the process of joining the facility,” she said, and countries are taking legal and budgetary steps needed to participate in this innovative global partnership. “We are actively collaborating with financial institutions, like the Inter-American Development Bank, to support countries in our region access the funding needed to purchase vaccines through the COVAX Facility when they are available. Etienne added.
“PAHO’s Revolving Fund, with more than 40 years of experience providing affordable and quality vaccines to countries in Latin American and the Caribbean, will be, along with UNICEF, the purchase mechanism for the COVAX facility,” she said.
In the Caribbean, 11 countries will receive financial support for initial payments to join the COVAX facility, she said, in collaboration with the Caribbean Public Health Agency and the European Union.
COVID-19 in the Americas
The PAHO Director noted that there have been over 40 million cases and over 1.1 million deaths worldwide due to COVID-19, including 18.9 million cases in the Region of the Americas and over 610,000 deaths as of October 20. “Across our Region, around 100,000 people continue to test positive for COVID-19 every day,” Etienne said.
Trends show cases rising in the United States and Canada and plateauing across Central America, while most new cases in the Caribbean are related to non-essential international travel, Etienne noted.
These spikes show that while the region is “hard at work preparing for a vaccine, we must also keep a strong and steady course to continue fighting the virus without one.”
She urged all countries to “prioritize a transparent and proactive communications approach for COVID-19. The people of our region crave clear guidance. Communicating effectively and consistently about what they can do to protect themselves and avoid infection remains vital.”
Etienne added that “Testing, treating and isolating cases, as well as tracing contacts are all part of a good surveillance strategy and too few countries are doing this well in our region. It is as important now as it was in April. And it will be even more important once we have a vaccine.”
The Pan American Health Organization (PAHO) works with the countries of the Americas to improve the health and quality of life of its population. Founded in 1902, it is the world’s oldest international public health agency. It serves as the Regional Office of WHO for the Americas and is the specialized health agency of the Inter-American system.
The Caribbean Public Health Agency’s Caribbean Regulatory System (CARPHA – CRS) has issued the first recommendation of a medicine to treat a rare disease.
To date, more than 130 medicines and other health technologies have been recommended by CARPHA-CRS to CARICOM Member States.
Fernanda Lessa - 15:47, 19 de October de 20201,865
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PAHO has published official Spanish version of the English original: WHO GLOBAL BENCHMARKING TOOL (GBT) FOR EVALUATION OF NATIONAL REGULATORY SYSTEMS OF MEDICINES AND VACCINES that is available at https://iris.paho.org/handle/10665.2/52851
Fernanda Lessa - 16:04, 29 de September de 20203,870
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Brazil counts now on the Medicines Nitrosamine Monitoring Special Program, developed by ANVISA to deepen investigation on impurities presence of Nitrosamine in active pharmaceutical ingredients (APIs) and medicines. The focus of such program are medicines of the category known as Sartans, generally used for high blood pressure control.
The program, which might get started in September, will be coordinated by the Agency and developed in two phases, with the collaboration of the National Institute of Quality Control (INCQS/Fiocruz).
Although considered chemical compounds usually found in water, vegetables and other food, in 2018 the N-nitrosamines or nitrosamines were detected in medicines, as result of changes in APIs manufacturing, bringing a global alert about its probable carcinogenic potential for humans.
Therefore, the nitrosamine monitoring program is one more ANVISA’s step towards protecting public health and to ensure quality, efficacy and safe of medicines for human use.
Phases
In the first phase of the program, companies interested in participating of the monitoring will be able to voluntarily send samples of medicines and APIs Losartan and Valsartan to the INCQS, which will perform laboratory analysis to identification and quantification of nitrosamines. Such interested companies must fulfill a form with product data, prior to sending it to INCQS.
In the second phase, samples of such products and also of others will be analyzed by ANVISA and by other entities of local (states and municipalities) health surveillance, pursuant to the provided on Law 6.437/1977. The chronogram of analysis of the program estimate investigation of a total of nine active principles up to June 2021.
Origen of nitrosamines
The N-nitrosamines or nitrosamines are compounds usually found in water, smoked food and grilled, dairy and vegetables. Its known that exposition to those compounds within the safe limits represents low risk to health grievances. However, beyond the acceptable levels and for prolonged periods, exposing to nitrosamines may increase the risk of cancer incidence.
In case of medicines, in July 2018, the German Regulatory Agency (Federal Institute for Drugs and Medical Devices – BfArM) and the European Medicines Agency – EMA withdrew the marketing of generics of Valsartan drug when was discovered that changes in manufacturing process of the API Valsartan took to origination of impurity N-nitrosodimethylamine (NDMA) in batches that were produced by a Chinese company.
In the following weeks, it was identified that the API of other manufacturers also had the same impurity. The NDMA is highly toxic, specially to the liver, and recognized as carcinogenic by studies performed in animals, being classified by the International Agency of Cancer Research as probably carcinogenic for humans.
Since those moment, it was observed the occurrence of reports about other APIs, of other therapeutic types, that also are known or suspected pioneers of contain NDMA and other nitrosamines potentially carcinogenic as well.
In Brazil, ANVISA withdrew approximately 200 batches of medicines of Sartanas type. Besides, the Agency suspended the manufacturing, import, supply, marketing and use of APIs with suspect of contamination. In total, were made 14 suspensions of three ingredients.
Considering the importance of this theme, ANVISA published, in May 2019, the Resolution of Board Directors (RDC) 283, which established the necessity of the productive sector to investigate, control and eliminate nitrosamines potentially carcinogenic in angiotensin II antagonists receptor, which have vasodilator function in the organism.
Therefore, the special monitoring program started now is a complement to the actions that have been already adopted by the Agency. It is important highlight that the voluntary participation of the interested in the first phase of the program aim to stimulate the adherence of the productive sector to adopt collaborative measures to face the problem.
The design of the program was presented in a meeting with the productive sector, hold on September 16th, 2020.
This document provides advice to manufacturers on both the process and the criteria that will be used by the WHO to evaluate COVID-19 vaccines that are submitted either for prequalification (PQ) or for Emergency Use Listing (EUL). The current status of development of a candidate Covid-19 vaccine, the extent of the available quality, safety and efficacy data and regulatory approvals by relevant NRAs will guide WHO’s decision on which pathway (PQ or EUL) to follow for each vaccine.
Comments are due by 8th October by email at the following address WHOEUL@who.int
The draft document on Policy on Evaluating and publicly designating regulatory authorities as WHO listed authorities is under public consultation until 15 September 2020.
