EN PL

News

Procedural advice on the certification of quality and non-clinical data for small and medium sized enterprises developing advanced therapy medicinal products

07.12.2016
Article 18 of Regulation (EC) No 1394/20071 provides that Small and Medium-sized Enterprises (SMEs) developing an Advanced Therapy Medicinal Product (ATMP) may submit to the European Medicines ...

RAPS: FDA Warns Teva’s Banned Hungary Manufacturing Facility

17.11.2016
The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as ...

EMA: EMA encourages companies to submit Type I variations for 2016 by end of November

17.11.2016
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to ...

RAPS: EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

17.11.2016
The European Medicines Agency (EMA) released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across ...

EMA: Revising the guideline on first-in-human clinical trials

17.11.2016
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN for veterinary medicinal products

17.11.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN ...

GMP: FDA´s Drug Safety Draft Guidance regarding REMS

17.11.2016
On September 20, 2016, the Food and Drug Administration (FDA) published a draft guidance for industry on the "Application of Statutory Factors in Determining When a REMS Is Necessary" ...

RAPS: EMA Transparency: New Clinical Reports Go Live

17.11.2016
The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a ...

RAPS: WHO Seeks API Manufacturers for Prequalification Program

25.10.2016
The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and ...

RAPS: FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

25.10.2016
The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing ...