Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
Coronavirus disease (COVID-19) is a new strain that was discovered in 2019 and has not been previously identified in humans.
Murilo Freitas - 18:24, 11 de December de 20191,104
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The Pan American Health Organization invites you to celebrate Universal Health Day 2019, with the theme “Universal health: everyone, everywhere” – Compact on Primary Health Care for Universal Health 2030.
The PAHO Director, Carissa F. Etienne, and representatives from the academic field, NGOs, and U.S. authorities will participate of the event. Speakers will talk about achievements and new challenges to achieve Universal Health by 2030, with reference to the Compact 30.30.30: Primary Health Care for Universal Health.
Murilo Freitas - 14:18, 3 de December de 20191,429
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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
Murilo Freitas - 16:17, 2 de December de 20194,818
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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.
Murilo Freitas - 10:42, 13 de November de 20192,290
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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 20191,316
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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 20192,372
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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.
