The EMA has announced a new timeline for the application of the Clinical Trials Regulation due to EMA`s move to Amsterdam because of the Brexit.
Ireland’s Health Products Regulatory Authority (HPRA) recently shared an advice for Academic Sponsors and has updated its guide to clinical trial applications.
The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of Electronic Data Files and Statistical Analysis Programs.
The US FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program.
Chinese manufacturer of active pharmaceutical ingredients Jilin Shulan Synthetic Pharmaceutical received an FDA warning letter in May 2018. It was criticised in particular that the Company did not record, investigate and solve laboratory OOS results. It was also criticised that the Audit Trails of the electronic laboratory instruments (HPLC, GC, IR) were not enabled. Find out more about the Jilin Shulan Synthetic Pharmaceutical Warning Letter.
The revised Annex 17 of the EU GMP Guide has been publised and will come into operation on 26 December 2018. Read more about the guideline on Real Time Release Testing and Parametric Release.
On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.
The US Food and Drug Administration (FDA) recently made available the ICH Q12 draft guidance on "Product Life Cycle Management" together with its Annex.
In a press release from 22 June 2018 the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future that are of great importance for the pharmaceutical industry. The Council intends to begin developing the ICH Guidelines Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14)" and "Continuous Manufacturing (Q13)". Find out more about this important ICH Press Release.
The European Medicines Agency (EMA) has published two updated documents on U.K.´s withdrawal from the EU - giving a lot of new Questions and Answers on Brexit.