EMA Says Complying With its Scientific Advice Raises Likelihood of Approval, Fewer Objections

Posted 20 April 2015 By Michael Mezher

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A new study authored by European Medicines Agency (EMA) staff finds that companies that followed the agency's scientific advice are more likely to get their products authorized.

Background

EMA provides scientific advice to companies for a fee in order to assist them in designing clinical trials through its Scientific Advice Working Party (SAWP). If a clinical trial is not well designed, it can be difficult to for the agency to conduct an assessment of the product and may lead to objections from reviewers.

While EMA collects fees from companies that request scientific advice, the agency offers reduced fees to certain products, including orphan medicinal products and advanced-therapy medicinal products (ATMPs). Products with a pediatric use designation may receive scientific advice free of charge. Additionally, small- and medium-sized enterprises (SMEs) qualify for reduced fees through the SME office.

The Study

To conduct the study, researchers used data from every marketing authorization application EMA issued an opinion for between 2008 and 2012. During this period, EMA received 232 marketing authorization applications and 143 requests for scientific advice. Of the requests for scientific advice, 118 were appropriate for assessment to determine whether the company complied with the agency's recommendations.

According to the researchers, two-thirds of the clinical programs submitted to the agency for scientific advice were "inadequate to generate data for the assessment of the benefits and risks of the medicine," without changes to the clinical trial design.

Benefits of Scientific Advice

When, in the course of providing scientific advice, EMA finds a company's trial design inadequate, the agency will provide advice to the company on how it can more appropriately design its study. EMA says that scientific advice provides companies a chance to "initiate a scientific dialogue on all aspects of the development of a medicine."

When companies' clinical trial designs were appropriate, meaning EMA did not suggest any modifications, their products were authorized 84% of the time. Similarly, when companies applied changes to their clinical trial designs per EMA's scientific advice, their products were authorized 86% of the time. In contrast, companies with inadequate clinical trial designs that did not follow EMA's recommendations only had their products authorized 41% of the time.

Applications that complied with EMA's scientific advice also faced fewer major objections than those that were not compliant. On average, applications that complied with EMA's recommendations were reviewed in 367 days versus 428 days for applications that did not follow EMA's advice.

Similar Conclusions for SMEs

A report commissioned by Deerfield and Europabio last month came to similar conclusions for SMEs, saying these companies could benefit greatly by engaging with regulators and health technology assessment (HTA) bodies early on.

The report found that applications that received multiple instances of scientific advice were more likely to be authorized than those that received scientific advice zero or one times during the application process.

EMA Press Release

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Categories: Drugs, Clinical, Preclinical, Regulatory strategy, Submission and registration, News, Europe, EMA

Tags: Scientific advice, Small- and medium-sized enterprise, SME

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