Recent News
FDA issues 2018 Compounding Policy Priorities Plan
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply,…
Read MoreIs an orphan medicine still an orphan once it gets on the market?
EMA publishes additional reports on decision-making for orphan medicines; initiative addresses requests from stakeholders The European Medicines Agency (EMA) will be publishing, as of today, a so-called orphan maintenance assessment report for every orphan-designated medicine which has been recommended for marketing authorisation by the Agency. The new report summarises the reasoning of the Agency’s Committee for Orphan Medicinal Products (COMP)…
Read MoreHow to better apply the paediatric legislation to boost development of medicines for children
EMA and European Commission invite stakeholders to register for joint workshop and support development of an action plan The European Medicines Agency (EMA) is inviting expressions of interest in a workshop organised together with the European Commission on 20 March 2018 to identify and discuss potential improvements to the implementation of the European Union’s (EU) regulatory…
Read MoreEvaluation of advanced therapy medicines
Updated procedural advice clarifies regulatory process for advanced therapy medicinal products The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to…
Read MoreStrengthened guidance on follow-up and risk management for ATMP developers
Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs) for a three-month public consultation. The revision is part of the joint action plan published by the European Commission and EMA in October 2017…
Read MoreIFAPP Is Now on Facebook
IFAPP has launched a new Facebook page. By adding a presence on this social media platform, IFAPP aims to keep members and interested persosns informed on the latest in pharmaceutical medicine and medicines development. We wish to thank Dr. Hasan Mahmood, founder and president of the Bangladesh Association of Pharmaceutical Physicians, for his leadership in this project. …
Read MoreIFAPP Signs MOU with WMA
Dr Honorio Silva, President of IFAPP and Dr Gustavo Kesselring, past-President of IFAPP, signed a Memorandum of Understanding with the World Medical Association (WMA) during the latter’s General Assembly held in Chicago on October 14th, 2017. Dr Yoshitake Yokokura, WMA President, signed the document on behalf of the World Medical Association. The signature of this…
Read MoreThe Fritz Buhler Scholarship
22nd Swiss Annual Symposium on Pharmaceutical Medicine
SwAPP and SGPM are pleased to invite you to the 22nd Swiss Annual Symposium on Pharmaceutical Medicine to be held in Metropol Zurich, 29 November 2017. IFAPP members, as well as SwAPP and SGPM members, enjoy a discounted registration fee. This year’s focus is Drug Development in Special Populations. An attractive mix of speakers will share…
Read MoreAfrica's Multi-Billion Dollar Pharma Potential
By 2020, Africa may well represent a US$ 65-billion opportunity for drug manufacturers. This is due to several factors, including increasing urbanization, a disproportionate disease burden, a projected rise in chronic illnesses across the continent, and greater international attention to the health challenges facing the African people. Africa’s pharmaceutical potential, as well as tips on…
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