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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 ...

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 ...

MHRA: MHRA's Interpretation of Cross Contamination & PDEs

23.03.2017
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be ...

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 ...

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 ...

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 ...

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 ...

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 ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on conducting research by the company Micro Therapeutic Research Labs in India

05.01.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on confirmation by EMA recommendation to carry out tests to detect hepatitis B among patients treated with antir

05.01.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on confirmation by EMA recommendation to ...