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GMP Oversight of Medicines Manufacturers in the European Union
Share: A System of Equivalent Member States, a Coordinating Agency and a Centralized Institution The regulatory system for supervision of pharmaceutical manufacturers and GMP inspection in the...
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EMA publishes finalised Process Validation Guideline for Biotech Products
Share: Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title...
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EMA’s new Draft Guideline on the Sterilisation of Medicinal Products, APIs,...
Share: For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA has recently published the draft...
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EMA publishes Q&A on data required for sterilized primary packaging materials...
Share: The European Medicines Agency, EMA, recently published questions and answers on what data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic...
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EMA reviews Medicines manufactured at U.S. Company
Share: Following the issuance of two Non-Compliance Reports for two sites of the US based company, EMA has started a review of medicines manufactured by Pharmaceutics International Inc., USA. The...
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Practical Implementation of the Control of Elemental Impurities: EMA’s new...
Share: One and a half year after its publication, the ICH Q3D guideline still raises many questions. The EMA has recently published a guideline draft aiming at clarifying the practical implementation...
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EMA/ FDA Mutual Recognition Agreement on drug facility inspections moving...
Share: EMA/ FDA Mutual Recognition Agreement moving forward A possible agreement between the EMA and the US FDA on mutual recognition agreement on drug facility inspections could already be signed...
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EMA issues new Guideline on “Chemistry of Active Substances”
Share: The new EMA “Guideline on the chemistry of active substances” represents the current state of the art in regulatory practice and fits into the context of the ICH Guidelines Q8-11. Find out what...
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EMA publishes Q&A on Health Based Exposure Limits – Does the 1/1000 dose...
Share: In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in...
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EMA modernizing the orphan designation process
Share: EMA modernizing the orphan designation process On June 19, 2018, the European Medicines Agency (EMA) launched a new secure online portal for Orphan Designation (OD) applications. The portal,...
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