The European Medicines Agency (EMA) has finalised their recently adopted guideline on good pharmacovigilance practices (GVP) module which provides recommendations for pharmacovigilance in paediatric populations. Read more “EMA finalises guideline on GVP considerations for paediatric populations”
News
FDA releases draft guidance on meta-analysis of randomised controlled clinical trials
The Food and Drug Administration (FDA) has released draft guidance on meta-analysis of randomised controlled clinical trials to evaluate the safety of human medicines or biological products. The FDA stated that conducting meta-analysis to evaluate safety questions presents a unique opportunity to detect and quantify the risk of a safety event and may help provide a more precise estimate of the risk of uncommon serious adverse events by combining information from multiple trials. Read more “FDA releases draft guidance on meta-analysis of randomised controlled clinical trials”
FDA delays enforcement dates for class I and unclassified device UDIs by two years
The Food and Drug Administration (FDA) has released new guidance which pushes back the date by which the FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices by two years. Read more “FDA delays enforcement dates for class I and unclassified device UDIs by two years”
FDA releases draft guidance on hepatitis B virus drug development
The Food and Drug Administration (FDA) has released draft guidance which aims to help sponsors who are looking to develop hepatitis B virus (HBV) treatments. The guidance covers general considerations on non-clinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials. Read more “FDA releases draft guidance on hepatitis B virus drug development”
European Commission releases guidance on UDIs
The European Commission has released five new guidance documents on the use of unique device identifiers (UDIs). The guidance covers UDIs for systems and procedure packs, definitions and descriptions of formats of the UDI core elements for systems and procedure packs, UDI assignment to medical device software, clarification of UDI responsibilities in relation to Article 16, and provisional considerations regarding language issues associated with the UDI database. Read more “European Commission releases guidance on UDIs”
Highlights from the October CHMP meeting
From their meeting in October, 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 six medicines for approval, including two orphan medicines. A new vice-chair of CHMP was also elected. Read more “Highlights from the October CHMP meeting”
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”
How is the MHRA working with Indian authorities to prevent unlicensed medicines entering the UK?
Indian law enforcement agencies are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to help prevent unlicensed medicines entering into the United Kingdom (UK). The MHRA plans to send intelligence to the Directorate of Revenue Intelligence (DRI), which enables them to target regions suspected of importing unlicensed medicines into the UK. Read more “How is the MHRA working with Indian authorities to prevent unlicensed medicines entering the UK?”
EMA enters third phase of Brexit preparedness business continuity plan
On 1st October 2018, the European Medicines Agency (EMA) entered into the third phase of their Brexit preparedness business continuity plan (BCP). During the third phase, the temporary suspension or decrease in additional activities will enable the EMA to safeguard core activities which are related to the evaluation and supervision of medicines, whilst the Agency acts on the consequences of the United Kingdom’s exit from the European Union (EU) in March 2019. Read more “EMA enters third phase of Brexit preparedness business continuity plan”
FDA launches Special 510(k) Program Pilot
Following the release of draft guidance that proposed expanding the device changes that would be eligible for the special 510(k) program, the Food and Drug Administration (FDA) has launched a pilot to put the planned changes into use. Read more “FDA launches Special 510(k) Program Pilot”