EMA publishes first series of EU MDR/IVDR guidance

The European Medicines Agency (EMA) has published the first of a series of guidance documents to help applicants prepare for the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first EMA guidance related to the new European Union (EU) MDR. Read more “EMA publishes first series of EU MDR/IVDR guidance”

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”

MHRA releases final consultation response for the Falsified Medicines Directive

A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”

Implementing ‘safety features’ under the Falsified Medicines Directive

Falsified medicines present a threat to public health in several ways, such as adverse reactions, interaction with other medicines and loss of faith in healthcare systems. Currently there is no mechanism that allows users to verify where a medicine has come from. The European Union (EU) Falsified Medicines Directive (FMD) aims to prevent falsified medicines from entering the legitimate supply chain and reaching patients. The ‘safety features’ policy requires a unique identifier and tamper-evident features to be added to prescription medicine packs by 9th February 2019.  Read more “Implementing ‘safety features’ under the Falsified Medicines Directive”

TGA Australia to implement process for comparable overseas regulators

Following a 2016 regulation that aimed to improve access to medical products in Australia, the Therapeutic Goods Administration (TGA) has implemented criteria to aid pharmaceutical companies in identifying comparable overseas regulators (COR), including a formal process for work-sharing on drug applications using foreign reports. Read more “TGA Australia to implement process for comparable overseas regulators”