Posted on 06 Dec 2018

Regulatory News - December 2018

Update of EMA pre-authorisation procedural advice for users of the centralised procedure.

The update was published on 01 Oct 2018; a clean and a tracked changes version are available here.

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population.

The guideline is available here. Besides the issues related to AE reports, ICSRs, and signal detection, the guideline provides some help with the preparation of the respective subsections of RMP and PSUR. In particular, it addresses the complexity of the paediatric population by dividing it into subpopulations, each with different physiology, organ maturity, and drug sensitivity. In addition, the guideline addresses medication errors, off-label use, and AEs clinical presentation in the paediatric population.

EMA Consultation: Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations.

The European Medicines Agency has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. This discussion paper has been prepared by the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative. The main objective of this initiative is to facilitate use of patient registries to support regulatory decision-making. The paper discusses methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes. Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. The discussion paper is available by clicking here.

European Commission published reports and other material on vaccination.

Vaccination policy is a competence of national authorities, but the European Commission assists EU countries in coordinating their policies and programmes. The Commission proposed in April 2018 a Council Recommendation to strengthen the EU cooperation on vaccine-preventable diseases. The initiative aims to tackle vaccine hesitancy, improve coordination on vaccine procurement, support research and innovation, and strengthen EU cooperation on vaccine-preventable diseases. All the reports are available by clicking here.

Fluoroquinolone and quinolone antibiotics: PRAC recommends new restrictions on use following review of disabling and potentially long-lasting side effects.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018. Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system. Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics. Detailed information on the PRAC recommendations for use of fluoroquinolone antibiotics is available here. The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell). Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.

Federal Register: Presenting Quantitative Efficacy and Risk Information on Direct-to-Consumer Promotional Labeling and Advertisements; Draft Guidance for Industry.
The Food and Drug Administration announced the availability of a draft guidance for industry entitled ''Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. This draft guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter (OTC) animal drugs (collectively promotional materials). FDA is issuing this draft guidance to describe the Agency's recommendations for how manufacturers, distributers, and packers (collectively firms) that include quantitative efficacy or risk information about their drugs in DTC promotional materials can make the language and presentation more consumer-friendly.