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
The Argentine National Administration of Medicines, Foods and Medical Technology (ANMAT) joins as an observer member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), in the framework of the Council´s meeting held at the beginning of June in Amsterdam, the Netherlands.
For 29 years the ICH has brought together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration to achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner.
According to ANMAT, achieving the role of observer of ICH is an important distinction, since it is the preliminary stage to be part of the Council as a «regulatory member», allowing to consolidate its position as one of the world National Agencies of Reference.
For more information go to ANMAT webpage: https://www.argentina.gob.ar/noticias/anmat-miembro-observador-de-ich
Central American Medicines Regulatory Authorities met to sign the “Joint Medicines Verification Mechanism” convention, which encourages the introduction of new drug therapeutic alternatives and thus benefit more than 40 millions of Central Americans. As witnesses of honor participated the representative of the Pan American Health Organization in Costa Rica (PAHO), Dr. María Dolores Pérez and the Vice-President of the Republic, Epsy Campbell Barr.
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For more information go to https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2019/1491-costa-rica-firma-mecanismo-de-verificacion-conjunta-de-medicamentos-de-centroamerica
With the support of several countries in the Americas and PAHO/WHO, Paraguay creates its model for universal and sustainable access to medicines and other health technologies, as well as their rational use, which will therefore benefit all public health services users.
For more information only in Spanish, go to https://www.mspbs.gov.py/portal/19750/nace-nuevo-modelo-de-gestion-de-medicamentos-que-marcara-un-hito-en-salud-publica.html
1 OCTOBER 2019 – WHO launches the School of INN (International Non-proprietary Names). INNs are global names for medicines. They provide one reference generic name for each individual medicine that comes to market. Since 1953, the World Health Organization has named over 10 000 medicines.
The School of INN is an online platform where students of pharmacy and medicine, health professionals, scientists, drug regulators, industry, international organizations and civil society can follow short course modules and learn more about the science of drug nomenclature and what INNs do in practice.
For more information go to https://www.who.int/medicines/news/2019/school-of-INN-launch/en/
It was published the document “Regulation of Advanced Therapy Medicinal Products: concept note and recommendations”, Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018).
The aim of this document is to highlight the progress made with regard to advanced therapy products, the risks associated with such products, and the regulatory challenges they pose for Member States with a view to strengthening regulatory systems. The document is also a call to action for governments to consider the development of standards and rules for regulating these products in order to control the use of unapproved therapies and prevent risks to the population. As discussed, there are cross-cutting regulatory principles that should be implemented by any regulatory body that plans to undertake the regulation and oversight of advanced therapy products.
Its rationale follows on previous discussions at the 2016 PANDRH Conference, and fulfills a recommendation by the Conference that requested PAHO to develop a concept paper on the subject.
The Regulation of Advanced Therapy Medicinal Products: concept note and recommendations, is available in English and Spanish, from:
