Murilo Freitas - 10:42, 13 de November de 20192,381
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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.
Murilo Freitas - 10:39, 11 de November de 20191,550
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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.
Murilo Freitas - 15:51, 28 de October de 20192,711
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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.
Murilo Freitas - 15:46, 28 de October de 20191,205
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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.
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.
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.
Murilo Freitas - 12:48, 23 de September de 20191,213
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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:
Murilo Freitas - 11:36, 17 de September de 20192,080
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It was published the document “Regulatory reliance principles: 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 outline key examples and principles for the practice of regulatory reliance. Its rationale is multifold: (a) it follows on previous discussions at the 2016 Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH), and (b) it fulfills a recommendation by the Conference that requested PAHO to develop a concept paper on reliance for PANDRH stakeholders to consider for endorsement. This concept paper builds on a presentation that was made at the 2016 Conference and integrates global thinking on the subject, including a recent document by the World Health Organization (WHO). The overarching goal is to ensure that PANDRH stakeholders continue to build understanding around reliance in ways that can better inform scenarios for its use.
CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.
The FDA and the European Medicines Agency (EMA) are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s Breakthrough Therapy Designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs. The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.
