Regulatory Focus™ > News Articles > European Regulators Highlight Surge of Small Businesses Seeking Scientific Advice

European Regulators Highlight Surge of Small Businesses Seeking Scientific Advice

Posted 21 February 2013 | By Alexander Gaffney, RAC

Small companies are starting to develop in big ways, the European Medicines Agency (EMA) explains in a posting on its website.

Those companies, which are referred to as micro, small and medium-sized enterprises (SMEs), generally represent the newest companies or those with the least amount of experience or capital to fall back on when putting forth an application for regulatory approval. So while a larger company might be able to shake off a small mistake-say, an omission in its dossier that requires additional data to be sent to EMA-the same mistake made by an SME could be disastrous to its ability to function.

Small Companies, Big Trends

So EMA said it is encouraged to see that an increasing number of companies are taking advantage of the scientific advice that it offers to companies, which is geared toward setting expectations and requirements for sponsors. Advice-seeking SMEs increased to 64%, up from 41% in previous years, regulators said.

"This increased interest is a good sign, because seeking scientific advice and complying with it has been associated with a greater chance of receiving a positive opinion," the regulator explained.

2012 also saw the first SME-generated request for biomarker qualification, which EMA said supports its ability to make rational regulatory decisions by making it easier to run an enriched clinical trial and generate more targeted data.

Mixed Results

Unfortunately, the increase hasn't corresponded with a similar increase in success, though such success would likely lag an increase in scientific advice-seeking by a year or more. EMA said SMEs received favorable approval notices in 53% of all cases, compared to a 78% average overall.

Despite the relatively lackluster numbers, SME approval averages are trending up, EMA said. "A positive trend was observed over the last four years: the rate of positive outcomes has been above 50% each year, averaging 63% over these four years."

This has been paired with a massive increase in the number of SMEs, up 62% in 2012 to 1,025 companies, of which 40% are so-called "micro" companies comprised of fewer than 10 staff members.

Regulators also called attention to increasing rates of compliance when it comes to quality, noting that fewer SMEs face major objections during the approval process related to the quality of their medicines.

Not all developments were positive, however. Non-clinical study design, pharmacokinetic and pharmacodynamics clinical studies and safety-related methodological concerns were all highlighted as areas of endemic deficiencies.


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