MHRA updates its “final determinations on borderline products”

MHRA has published an updated list of final determinations issued by the Borderline division within the agency. Details of the product names, the names of the companies to whom the determination notices were issued and brief details of the reasons for the determination are provided. Read more “MHRA updates its “final determinations on borderline products””

Swissmedic updates guidance on orphan drugs and paediatric investigation plans

The Swiss Agency for Therapeutic Products (Swissmedic) has updated their guidance on orphan drugs and paediatric investigation plans (PIPs). Topics addressed include orphan drug fees and the documentation companies need to supply to support European and American PIPs. Read more “Swissmedic updates guidance on orphan drugs and paediatric investigation plans”

EMA provides update on Brexit in their March 2019 Management Board meeting

Following the agreement between the United Kingdom (UK) and the European Union (EU) to extend the Brexit deadline, during the European Medicines Agency’s (EMA) Management Board meeting in Amsterdam they stated that the prospect for centrally authorised products to be at risk of shortage “continues to decrease”. However, the agency has warned that if the UK were to leave the EU with no-deal, then there is still a high risk of supply issues with some medicines. Read more “EMA provides update on Brexit in their March 2019 Management Board meeting”

Highlights from the February CHMP meeting

From their meeting in February, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced the recommendations of eight medicines for approval, including two orphan medicines. For three out of the eight new medicines, the CHMP recommended a conditional marketing authorisation. Read more “Highlights from the February CHMP meeting”

European Union advances towards adopting SPC waiver proposal

The European Union (EU) is adopting new rules which aim to increase the competitiveness of EU producers of generic medicines and biosimilar products. The EU’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) advances after EU ambassadors approved a compromise that was reached on 14th February with the European Parliament during a meeting of the Committee of the Permanent Representatives. Read more “European Union advances towards adopting SPC waiver proposal”

EMA opens consultation on the role of ‘big data’ for evaluation and supervision of medicines in the EU

As part of a report of the Heads of Medicines Agencies (HMA) – European Medicines Agency (EMA) Joint Big Data task force, recommendations and associated actions have been outlined for understanding the acceptability of evidence which is derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. Read more “EMA opens consultation on the role of ‘big data’ for evaluation and supervision of medicines in the EU”

Partial US Government shutdown is straining the FDA

A partial United States (US) Government shutdown has hindered the Food and Drug Administration’s (FDA’s) ability to accept and review regulatory submissions. A notice from the FDA on Government funding lapses, which started in December 2018, states that currently the FDA has no legal authority to collect user fees assessed for their 2019 fiscal year, which prevents the FDA from accepting new regulatory submissions such as 510(k)s and Premarket Applications (PMA) that require fees until Congress and the White House restore full funding. If you are planning to submit applications for US market authorisation in early 2019, you should factor these operational delays at FDA into your commercialisation plans. Read more “Partial US Government shutdown is straining the FDA”