The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.
Due to the Covid-19 pandemic, the EU had decided to postpone the date of application of the Medical Devices Regulation by one year to 26 May 2021. What consequences does this have for the industry?
The CMDh and CMDv recently published a revised version of the Q&A paper regarding variations including a new question on how to notify about an update of the QPPVs contact details.
The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.
GCP Inspectors from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA have published a joint paper on data integrity in global clinical trials.
The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute.
The FDA issued a Warning Letter to a manufacturer of aseptic homeopathics in Canada after the deficiencies listed in a 483 letter sent last October were not satisfactorily addressed.
Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.
The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.
The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in the GMP environment for decades. For some years now, health-based exposure limits have been added as a possible alternative. In a draft guideline, the WHO has addressed this topic.