Maas & Peither, GMP-Publishing

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The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) published a whole new round of warning letters. They are addressed to three manufacturers from the US and five in Brazil, the Netherlands, Germany, China and Bulgaria.
US Warning Letters were sent to:
SyncThink, who was warned for marketing an eye...

According to the ICH (International Council for Harmonisation), the ICH Q11 Q&A reached Step 4 of the ICH process in August 2017. The document is now entering Step 5 – the implementation period.
Initiated already in 2014, the Question and Answer document on the development and manufacture of drug substances is intended to provide additional...

The British Medicines and Healthcare products Regulatory Agency (MHRA) is dealing with the outcome of the EU referendum to move things into the right direction for the post-Brexit period.
On 21 August 2017, a position paper on the “Continuity in the availability of goods for the EU and the UK” was published by the MHRA that clearly states the...

The European Medicines Agency EMA, the European Commission and the US FDA have signed a new confidentiality commitment. It enables US- and EU regulators to share non-public and commercially confidential information, including trade secret information relating to medicine inspections. This can be considered a real milestone in the ongoing...

The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The agency will need to be relocated in the context of the UK's withdrawal from the EU. There have been 19 offers to host the European Medicines Agency (EMA).
The cities that have applied to host the EMA as of...

The government of India has published a draft document on the „Essential Principles for Safety and Performance of Medical Devices“, e.g. fundamental design and manufacturing requirements. It provides an overview on meeting these principles leaving flexibility to the manufacturers rather than dictating how a manufacturer should prove that the...

According to the published 15-page document that summarises the negotiating results of the Economic Partnership Agreement between the EU and Japan, the MRA (Mutual Recognition Agreement) in the area of GMP will be expanded to new pharmaceutical products. This is considered a major achievement after numerous attempts and years of discussion. It...

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. “With changing international policies in...

The European Council has published a timetable for the relocation of the Euorpean Medicines Agency (EMA) that is currently based in London. The following graph illustrates the procedure for the relocation due to the UK's withdrawal from the European Union:
Source: European Council

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.
Medical gases are regulated as pharmaceutical finished products by...