EMA Improves the Readability of Packaging Leaflets - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Improves the Readability of Packaging Leaflets


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Leaflets will now include less rigid language and new sections that provide greater information about a drug’s benefits. There will also be more information about the medicine’s use in children to comply with the requirements of pediatric regulation.

The update addresses feedback received during a five-year period of user testing. Stakeholders, including patients, pharmaceutical companies, and national regulatory agencies also contributed their opinions. In addition, the update takes into account the EMA’s 2009 report on the expectations of patients, consumers, and healthcare professionals regarding benefit–risk information, which explains how patients are becoming increasingly involved in choosing their own treatments. In particular, the report called for clear information that is easy to read and understand.

The readability of packaging leaflets and labels is an issue that Pharmaceutical Technology Europe touched upon in May during an interview with Professor DK Theo Rynor. He explained that a number of commonly-used phrases, such as “Avoid alcoholic drink”, are often misunderstood by patients.

According to a statement from EMA, the update also includes changes to the templates for the summary of product characteristics, labeling and 'Annex II', the section of the product information covering the conditions imposed on marketing authorizations. The updated templates are available in all official EU languages, together with an implementation plan.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
29%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here