The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.
The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.
EMA publishes Draft on Quality Requirements for Combination Products
The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?
The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.
New Zealand proposes new legislation for medical cannabis
New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.
ATMPs in combination with a medical device - QP task on release
With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.
How to handle possibly lifesaving OOS batches of ATMP - A question that concerns manufacturers and authorities
In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.
Transmission of multiresistant microorganisms during transplantation
Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.