The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.
EMA adopts final Public Statement on Pyrrolizidine Alkaloids
The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.
FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients
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.
EUDAMED - Current Status of the Database for Medical Devices
The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.
New Version of the Q&As on Safety Features for Track & Trace
The European Commission has published Version 18b of the "Questions & Answers" on safety features. In particular the update took into account the new ISO standard for Packaging Tamper verification features.
Recall of Product Samples from U.S. Market Due to Improper Storage Temperature Conditions
A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
ICH E6 GCP Guideline: Updated GMP for IMP Principles
The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs.
Track & Trace: Amendment of the Delegated Regulation on Safety Features
On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.
Switzerland aims to Facilitate Access to Medicinal Cannabis
The Swiss Narcotics Act is to be amended. Among other things, the amendment provides that cannabis-based treatments can be prescribed directly by doctors without having to obtain an exceptional authorization from the Swiss Federal Office of Public Health. In addition, cultivation and export are to be permitted.