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News about GMP/cGMP

2017-07-26

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has recently published its 51st report (Technical Report Series No. 1003). The WHO Technical Report Series covers the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on medical and public health subjects. TRS No. 1003 summarises the outcome of the Expert Committee Meeting of October 2016 in Geneva. In addition, the 252-page report contains all adopted guidances or draft guidances in the form of Appendices.

 
2017-07-14

According to pharmabiz.com, India is planning to set up a joint pharmaceutical venture in the region of Chelyabinsk in Russia and is now seeking views and suggestions from its pharmaceutical industry. On July 17, a interactive meeting with government senior officials and industry leaders will take place.

 
2017-07-11

As a result of the revised Swiss Therapeutic Products Act of March 2016, the relevant ordinances also need to be comprehensively adjusted. This affects ordinances issued both by the Federal Council and the Agency Council of Swissmedic and will last until October 2017.

 
2017-07-04

The European Council has published a timetable for the relocation of the Euorpean Medicines Agency (EMA) that is currently based in London.

 
2017-06-30

On June 28, 2017 the US FDA (Food and Drug Administration) published a revision of its draft guidance on medical gases entitled „Current Good Manufacturing Practice for Medical Gases Guidance for Industry“. This document is intended to supersede the guidance already issued in 2003.

 
2017-06-28
 
2017-06-28

According to ICH, the China Food and Drug Administration (CFDA) has been approved as a new Regulatory Member.

 
2017-06-20

According to a press release by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the German Federal Institute for Drugs and Medical Devices), a counterfeit pack of Gilead Sciences’ hepatitis C drug Harvoni® has entered the legal supply chain in Germany. The “falsified medicinal product” was identified by a patient who noticed a change in colour which was orange instead of white.

 
2017-06-14

The China Food and Drug Administration (CFDA) released a detailed report on inspections conducted throughout the last year. A total of 431 inspections including pre-approval inspections, GMP certification inspections, GMP follow-up inspections, unannounced inspections, overseas inspections, GSP unannounced inspection and inspection observations are analysed therein.

 
2017-06-13

Following a Notice to MAHs (Marketing Authorisation Holders) based in the UK the European Medicines Agency EMA and the European Commission have now released a Q&A document regarding the withdrawal of the UK from the European Union. It should help the pharmaceutical industry to prepare for the upcoming changes.

 
2017-06-06

According to the Swiss Therapeutic Products Agency Swissmedic, the agency achieved its objectives last year. Regulatory approval was granted for more than 40 innovative medicinal products partially due to a fast-track procedure.

 
2017-06-06

In collaboration with APEC (Asia Pacific Economic Cooperation), the US FDA has created a Supply Chain Security Toolkit for Medicinal Products. The intention behind this new tool is to maximize available global resources and to deliver quality trainings and best practices in order to secure the global supply chain. It covers the entire supply chain and lifecycle from raw materials to use by patients.

 
2017-05-26

On May 11, 2017 the US FDA issued a warning letter to Jintan Qianyao Pharmaceutical Raw Material Factory in Changzhou, China, for significant deviations from cGMP for APIs. The findings can be summarized as a complete lack of written procedures, quality-related procedures or an overall quality system.

 
2017-05-23

In January 2017, the FDA issued the long-awaited Biosimilar Interchangeability Guidance for public consultation. In this guidance, the Agency details its expectations for demonstrating biosimilar interchangeability.

 
2017-05-16

The GMDP Inspectorate of the British MHRA (Medicines & Healthcare products Regulatory Agency) has published its yearly report on inspection deficiency findings. This time the method of gathering the data has been improved, thus introducing new data trending.

 
 
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