Maas & Peither, GMP-Publishing

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The Economic Times of India has published an article saying that the Indian government has issued showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.
The eight Chinese companies who could be...

Maas & Peither, GMP-Publishing

 •  December 21, 2017

On 20 December 2017 the European Commission has published the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The public consultation period is open from 20 December until 20 March 2018. Since then, Annex 1 on sterile manufacturing has undergone a number of targeted updates. But the multitude of regulatory changes...

Maas & Peither, GMP-Publishing

 •  December 20, 2017

Three years after the publication of a concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, the ICH has now published the Step 2 draft document including an Annex with illustrative examples. The document was endorsed on 16 November 2017. The intention behind ICH Q12 is to provide guidance on a...

Maas & Peither, GMP-Publishing

 •  December 17, 2017

The EMA (European Medicines Agency) and the European Commission have published an updated version of the Q&A document which is intended to help the pharmaceutical industry to organise the UK’s withdrawal from the EU for their company.
The document now includes additional information on marketing applications and authorisations for different types...

Maas & Peither, GMP-Publishing

 •  December 5, 2017

On 24 November 2017, the European Medicines Agency has published a practical guidance document on post-Brexit Changes. The Practical Guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure comes in the form of nine questions and answers and outlines the...

Maas & Peither, GMP-Publishing

 •  November 29, 2017

On 24 November 2017, the European Commission has published the final version of the Guidelines on GMP specific to Advanced Therapy Medicinal Products. The term “Advanced Therapy Medicinal Products” (ATMPs) is used to designate gene therapies, somatic cell therapies and tissue engineered products.
According to the European Commission, the 90-page...

Maas & Peither, GMP-Publishing

 •  November 29, 2017

According to the Swiss Federal Office of Public Health FOPH, Switzerland is revising its medical devices legislation, closely modelled on the various new EU requirements aiming at an improvement on the safety and quality of medical devices.
The medical devices regulation in Switzerland goes back to January 2002. Since then it has been continuously...

Maas & Peither, GMP-Publishing

 •  November 21, 2017

The city to host the new headquarter of the European Medicines Agency EMA is chosen. Amsterdam emerged as the winner ahead of Milan and Copenhagen, the two other cities that reached the second and final round.
27 EU Member States took the decision on where to move the EMA which employs over 900 people. The final winner Amsterdam was drawn by lot...

Maas & Peither, GMP-Publishing

 •  November 15, 2017

In July 2017 the German Federal Ministry of Health (BMG) entered into a sponsoring contract with Maas & Peither GMP Publishing. From now on, the BMG will involve GMP Publishing in the official translation of the EU GMP Guide and its annexes.
In this cooperation, we shall provide the BMG with German translations of the documents and we shall be...

Maas & Peither, GMP-Publishing

 •  November 8, 2017

A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities: “Elemental impurities: If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk, a risk assessment according to general chapter 5.20...