The recently published EMA Annual Report 2021 gives a good overview of the Agency's activities in the first chapter, such as actions related to the management of the COVID 19 pandemic, work related to the scientific evaluation of medicinal products and their monitoring.
Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.
Benefit-Risk Assessment for Product Quality Evaluation
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.
With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". With some interesting results that perhaps not everyone would have expected.
In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.
Interpretation of 21 CFR 211.67 Cleaning of Equipment
The US-American GMP regulations for medicinal products are laid down in 21 CFR 211. Section 21 CFR 211.67 requires the establishment of and adherence to written instructions regarding the cleaning and maintenance of equipment. What is exactly meant by this?
MHRA introduces external consultants as Compliance Monitors in Companies
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project for a new Compliance Monitor Process. External consultants are being used for this purpose.
FDA plans Rating System for pharmaceutical Companies
The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.
FDA Warning Letters for Products Containing CBD and Delta-8 THC
The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.
Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?