EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications at the two agencies between 2014 and 2016. The study also looked at applications for which the agencies had differing …
EMA and the US Food and Drug Administration (FDA) have published today a report on their joint workshop with stakeholders held on 26 November 2018. The aim of this workshop was to discuss scientific and regulatory approaches to address quality and manufacturing challenges encountered during the development of medicines under early access programmes, such as the PRIority MEdicines scheme (PRIME) …
Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario. Contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency (MHRA) to be able to take on regulatory processes for human medicines and devices that are currently …
Generic and biosimilar medicines manufacturers will continue to benefit from existing qualified rights to make SPC-protected medicines in the UK for export or stockpiling in a ‘no deal’ Brexit scenario, the UK government has confirmed. SPCs, or supplementary protection certificates, serve to extend the life of patents owned by pharmaceutical manufacturers by up to a maximum of five years. The …
Starting August 19, 2019, pre-assigned NDA, IND, BLA and DMF number requests can be submitted via the CDER NextGen Portal. The FDA made this option available for abbreviated new drug applications (ANDAs) in June 2019. What are the benefits of submitting requests via the Portal? · Ease of Use: Requesting via the Portal is easy, and all information regarding your …
The U.S. Food and Drug Administration issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry. The revised draft guidance incorporates public comments received on the initial draft and provides FDA’s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatrics disease as one that is a …
Guidance Documents 7/26/2019 – Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry 7/23/2019 – Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry 7/22/2019 – Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff CDRH Update Weight-Loss and Weight-Management Devices (Updated)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a 12-week consultation on how to best engage and involve patients in the Agency’s work. The responses will help inform the MHRA’s future engagement with patients and the public. The MHRA wants to adopt a more systematic approach to listening to and involving patients. They want to make sure …
ccording to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format. Changing the electronic format of a …
Information on the ‘Written Confirmation’ process, for active substances manufactured in the United Kingdom (UK), that will be adopted in a no deal Brexit. These guidences can be found here