The EU Commission has now published the second corrigendum to the MDR and the second corrigendum to the IVDR in the Official Journal of the EU (OJEU). The key change to the MDR states that devices classified as Class I under the MDD can continue to be placed on the market until the 26 May 2024 if the following conditions are met: The …
Due to the possibility of a no-deal brexit, the UK MHRA have released detailed guidance on a varity of topics. These are all collated into the “MHRA guidance and publications about a possible no-deal Brexit” On the 7th and 8th of August the HMRA added 10 new guidances which are listed below: Further guidance note on the regulation of medicines, …
The U.S. FDA has announced the availability of a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” This describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it provides an overview of the types of clinical studies that sponsors may perform and data sources they may use during …
The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) signed a Memorandum of Understanding (MoU) between the two parties in Washington D.C. on Friday 26 July 2019. The agreement will enable improved collaboration and knowledge sharing between the BP and the USP in a wide area of standards setting for medicines. One of the features of this agreement is the …
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 …