Maltas Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.
The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.
The U.S. Food and Drug Administration has set a narrow window for the submission of risk assessments on nitrosamine impurities for drugs containing chemically synthesised APIs. Read more here about the arguments used by the pharmaceutical industry to request an extension of the deadline and the reasons given by the FDA for rejecting this request.
Are you familiar with a "non-paper"? This is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol.
During an inspection of an Indian pharmaceutical manufacturer by the FDA, several serious deficiencies were discovered. For example, the cleaning of multipurpose equipment was criticised, and the transfer of a non-validated manufacturing process led to further complaints. Read more here.
Combination products are products that are subject to different sets of regulations. Such products may, for example, consist of a drug and a medical device, or a biological component may be added. Because of the different product components, special monitoring procedures are required.
We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to Notified Bodies on remote audits have been published.
With the EU regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostics (IVDR) coming into force on May 21, 2021, new requirements have been/will be imposed on combination products with regard to their medical device component. There is an updated question and answer document (Q&A) from the European Medicines Agency on current issues.
In January 2020, EMA published a draft of a so-called reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder". Now the final document has been published.
In a letter sent directly to Janet Woodcock, FDA, the Congress of the United States expresses its concerns about a backlog of pharmaceutical manufacturing facility inspections and human drug applications.