The updated European Medicines Agency (EMA) draft guideline on environmental risk assessment (ERA) now contains a decision tree which clarifies when ERA studies are required, and provides greater detail on technical guidance to help increase the consistency of the assessments. Performing an ERA is mandatory for any pharmaceutical company submitting a marketing authorisation application for a medicine. Read more “EMA revises guideline on environmental risk assessment of human medicines”
Category: Medicinal product
UK Government announces legalisation of medicinal cannabis
From 1st November 2018, patients in the United Kingdom (UK) can be prescribed medicinal cannabis by specialist doctors. These specialist doctors can legally issue prescriptions for cannabis-based medicines when they agree that their patients could benefit from this treatment. The law change has come after the Home Secretary listened to concerns from parents of children with conditions such as severe epilepsy. Read more “UK Government announces legalisation of medicinal cannabis”
First CAR-T therapies approved by European regulators
The first chimeric antigen receptor T-cell therapies (CAR-T), named Kymriah and Yescarta, have been approved by European regulators, enabling patients to access CAR-T therapies for the first time. Read more “First CAR-T therapies approved by European regulators”
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”
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”
Targeted stakeholder consultation from the European Commission on duplicate marketing authorisations for biological medicinal products
The European Commission (EC) is seeking consultation on proposed clarifications for handling duplicate marketing authorisations (MAs). Under certain circumstances the EC is allowed to issue duplicate MAs when issues with existing patents in certain Member States occur and for other public health reasons. Read more “Targeted stakeholder consultation from the European Commission on duplicate marketing authorisations for biological medicinal products”
Are you looking to apply for a wholesale dealer licence?
Individuals or companies that sell or supply human medicines to anyone other than the patient must have a wholesale dealer licence. One of the most important aspects of wholesale distribution is maintaining the integrity of the supply chain and preventing falsified medicines from getting to the public.
Here are some top tips on customer and supplier verification to consider when applying for a wholesale dealer licence: Read more “Are you looking to apply for a wholesale dealer licence?”
TGA Australia implements pathway for provisional registration of prescription medicines
The Therapeutic Goods Administration (TGA) Australia are implementing a pathway for the provisional registration of prescription medicines, which is part of the Government’s response to the Review of Medicines and Medical Devices Regulation (MMDR review). Approval through the provisional pathway will be on the basis of preliminary clinical data where a substantial benefit is foreseen for Australian patients. Read more “TGA Australia implements pathway for provisional registration of prescription medicines”
European Commission releases new guideline on excipients in the labelling and package leaflet of medicinal products in the EU
The European Commission has released a new guideline which provides marketing authorisation holders (MAHs) with a list of excipients that should be included on a medicine’s label and the information for those excipients that must appear on the package leaflet. Read more “European Commission releases new guideline on excipients in the labelling and package leaflet of medicinal products in the EU”
FDA finalises ICH Q&A guideline on the development and manufacture of drug substances
The US Food and Drug Administration (FDA) has finalised the International Council for Harmonisation’s (ICH) question and answer (Q&A) guideline on the development and manufacture of drug substances. Read more “FDA finalises ICH Q&A guideline on the development and manufacture of drug substances”