News
RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India
23.03.2017
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis
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FDA: Hypertension Indication: Drug Labeling for Cardiovascular
23.03.2017
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling
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EMA: Regulatory cooperation to improve global health
23.03.2017
EMA experts meet with African regulators to discuss opportunities for collaboration.
How to improve the availability of high quality, safe and effective medicines to patients in countries
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EMA: Release of documents on two medicines temporarily halted
23.03.2017
Release of documents on two medicines temporarily halted.
EMA’s appeals against interim measures are dismissed by Court of Justice.
The Vice-President of the Court of Justice ...
EMA’s appeals against interim measures are dismissed by Court of Justice.
The Vice-President of the Court of Justice ...
MHRA: PIC/S statement to European Commission's ATMP GMP Guideline
23.03.2017
During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products
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EMA: Promoting high-quality clinical research in children through strengthened international collaboration
10.02.2017
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take
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FDA: Considerations in Demonstrating Interchangeability With a Reference Product
10.02.2017
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing
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RAPS: CDRH Warns Three Foreign Medical Device Manufacturers
10.02.2017
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal products for human use
10.02.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal
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RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars
05.01.2017
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is
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