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”
Category: Regulation
Highlights from the July CHMP meeting
From their meeting in July, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the July CHMP meeting”
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”
Highlights from the June CHMP meeting
From their meeting in June, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the June CHMP meeting”
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”
EMA to open secure portal for orphan drug designations
The European Medicines Agency (EMA) is launching an online portal for orphan drug designations. The EMA wants sponsors to start using the portal from 19th June 2018, in anticipation of it becoming mandatory in three months’ time. Read more “EMA to open secure portal for orphan drug designations”
Highlights from the May CHMP meeting
From their meeting in May, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the May CHMP meeting”
EMA adopts ICH Q&A on non-clinical evaluation of anticancer drugs
The European Medicines Agency (EMA) has adopted the International Conference on Harmonisation’s (ICH) questions and answers (Q&As) guideline on the non-clinical evaluation of anticancer drugs. Read more “EMA adopts ICH Q&A on non-clinical evaluation of anticancer drugs”
Highlights from the April CHMP meeting
From their meeting in April, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the April CHMP meeting”
FDA revises draft guidance on metered dose and dry powder inhalers
The United States (US) Food and Drug Administration (FDA) have revised draft guidance on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (MDIs)) and inhalation powders (also known as dry powder inhalers (DPIs)). The guidance describes points to consider in order to ensure product quality and performance for MDIs and DPIs. It states chemistry, manufacturing, and controls (CMC) information recommended for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Read more “FDA revises draft guidance on metered dose and dry powder inhalers”