April 2023 Monthly Newsletter

Understanding the differences between drug registration requirements in Europe and the US is essential for pharmaceutical companies.
While both regions aim to ensure public health, there are significant variations in the regulatory guidelines, expectations, and requirements.

As part of efforts to improve its services, Gulf Central Committee (GCC) in collaboration with Gulf Central Committee for Drug Registration (GCC-DR) introduced measures to make information about pharmaceutical products more accessible to patients and the healthcare industry. In 2023, Gulf Health Council and member states are working on a system that will be published.
PLG can provide clients with end-to-end labelling management support, as our team has extensive expertise in managing global and regional drug labelling and using enterprise-resource-planning systems such as SAP to support the artwork review process.

Industry bodies and universities have provided valuable feedback on the USFDA’s M11 guidance on Clinical Electronic Structured Harmonised Protocol and protocol template release. By creating a harmonised protocol template, this guidance aims to improve the efficiency of regulatory submission and facilitate review and assessment by various stakeholders.
Some of the critical findings expressed by the community include data sharing, diversity plans, and reporting procedures for safety measures. It is promising to see the industry and academic community collaborating to improve clinical trial protocols.

The USFDA has released a draft guidance for Product-Specific Guidance Meetings for ANDA applicants, under the Generic Drug User Free Act (GDUFA), to help the generic industry have clear pathways for developing complex generics.
The guidance covers the different types of PSG meetings between applicants and FDA, such as PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings, as well as the guidelines and documents required for each meeting.