EMA Explains How To Make Risk Minimization Measures Robust & Effective

Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines.

Hands of general practitioner filling paper medical records. Doctor in white coat doing paperwork at workplace with laptop, writing notes, preparing documents, reports, prescription. Close up
Patient and doctor representatives can contribute to user-testing of risk minimization materials • Source: Shutterstock

The European Medicines Agency’s updated guideline on risk minimization and the measures drug sponsors should take to ensure their products are used safely places greater emphasis throughout on the need to involve health care professionals and patient representatives in designing, testing, disseminating and evaluating the effectiveness of such measures.

Key Takeaways
  • The European Medicines Agency held a webinar to discuss its revised guideline on risk minimization measures (RMMs) and the related addendum on evaluating RMMs.

While most risks for drug products can be sufficiently managed by routine risk minimization measures (eg, summary of product characteristics,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.

MHRA Backs Global AI Framework For Pharmacovigilance Over UK-Specific Guidance

 
• By 

The UK’s medicines regulator wants to ensure that guidance on the use of artificial intelligence in pharmacovigilance processes remains fit for the future.

Cosmo Wins Over EMA With Risk Minimizing Measures And Expert Advice For Winlevi

 

The European Medicines Agency says that Winlevi should be approved in the EU for treating acne, having previously turned the drug down.

Navigating Rare Disease Submissions: Minoryx Stresses Early EMA Engagement

 
• By 

Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

More from Agency Leadership

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By 

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.