January 27, 2014

Early Communication with Regulators is Essential for SMEs

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

Europe’s regulatory agencies have been stepping up their support for small- and medium-sized enterprises (SMEs), including micro companies, in an effort to stimulate more development of innovative medicines. The companies are being offered free or heavily discounted regulatory and administrative assistance, training sessions, evaluation, and above all, scientific advice that can raise the chances of a new medicine gaining marketing approval.

The importance of early dialogue with regulators
Companies are encouraged to contact the agencies as early as possible during the drug-development stage to ensure that their manufacturing processes, in particular, will not lead to regulatory difficulties. It is, however, hard work for the regulatory agencies because many small companies (a high proportion of which are startups founded by individual specialists or small groups of scientists) tend to delay contacting the regulators until product development is close to the preclinical or clinical-trial stage. For the agencies themselves, the promotion of innovation can be a new role with which they need to become more familiar with to bridge any communication gaps with entrepreneurs.

“The people running SMEs know the science and technology of the area in which they are doing business,” explains Hooshang Zavareh, founder of ChemPharmServe, Cambridge England, a company that specializes in drug-development services. “They often don’t see the need for help from regulators until they get to the point where they need to make a regulatory application. If they want outside help before then, they will go to a consultant.”

Nonetheless, the agencies believe that having much closer ties between themselves and entrepreneur innovators is essential. With Big Pharma cutting down on research activities, they believe much of the impetus behind innovation in medicines--at least in the early stages of development--will come from the companies with low turnovers and few employees, for example micro companies with less than 10 employees and annual revenues of less than €2 million (approximately $2.7 million), SMEs with not more than 50 personnel and annual turnovers not exceeding €10 million, and medium enterprises of less than 250 employees and an annual turnover of not more than €50 million.

SMEs on the rise
The European Union is currently calling SMEs “the powerhouse” of its Innovation Union, a concept behind its new seven-year €77 billion research program called Horizon 2020, which starts next year. Approximately 10% of the program’s budget will be allocated to healthcare, demographic change, and well-being. A major objective is the elimination of fragmentation in the fields of scientific research and innovation. Among the EU’s regulatory agencies in pharmaceuticals, the most active in championing innovation has been the European Medicines Agency (EMA), which is responsible for centralized approvals of medicines, including those based on novel technologies and orphan medicines.

SMEs make up a growing proportion of companies applying to the EMA for an initial evaluation of a new medicine, including its manufacturing process. Almost 30% of applicants in 2012 were SMEs, which also accounted for 68% of evaluation applications for orphan medicines compared to 27% in the previous year

In 2012, the number of SMEs registered with the agency rose 62% to 1098 mainly because of fees reductions and also because companies could make electronic submissions of product information. This year, the rate of increase has slowed down with the total registrations by late November going up only a further 12% to 1234. Of this total, 43% were micro-sized companies, 12% were academic spin-offs, and 5% of registrated SME companies had been created since January 2012. The registered SMEs had a total of approximately 3000 products under development.


Tags: drug approvals, QbD, process development, regulators, regulatory agencies