Maas & Peither, GMP-Publishing

Share

On 16 October 2017, the EMA (European Medicines Agency) has published its 17-page Business Preparedness Plan to ensure continuity of the Agency’s operations once the United Kingdom is no longer a member country of the European Union. The plan identifies three main priorities: Not to jeopardise EMA’s positioning in the pharmaceutical arena in the...

According to Swissmedic, the new Article 64a of the revised Therapeutic Products Act (revTPA) will already enter into force on 1 January 2018. This Article governs cross-border inspections and includes inspections carried out in Switzerland by foreign authorities, as well as inspections by Swiss authorities abroad. What are the changes from...

The European Medicines Agency EMA has clarified its process for lifting a GMP non-compliance statement. The new process is outlined in an update to the question and answer document on GMP of the EMA.
Regarding the question on how a GMP non-compliance statement can be lifted the newly added question/answer 5 in the section on “GMP certificates,...

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...