Building an EU regulatory strategy (2)

2. Understand the application process

All biotech products, must be approved by the centralized procedure, which reviews products for approval in all member states. This procedure is also mandatory for orphan medicinal products, advanced therapy medicinal products (gene therapy, cell therapy and tissue-engineered products) as well as new new active substances intended for the treatment of HIV/Aids, cancer, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions. Everything in the centralized procedure is done electronically, but the entire process can still take up to a year. 

Once you've applied for marketing authorization in the centralized procedure, the EMEA appoints representatives from two member states to review your application. You can't request specific representatives, but member states can bid on applications. And here's where your relationship with regulators can have an impact. As they're already familiar with your work, the regulators you've been communicating with up this point may bid for the opportunity to review your application.

Kirke recommends that companies start the process by seeking scientific advice in two or three member states. The next thing companies need to do? Take the advice.

Regulatory agencies don't take being ignored lightly; a snub may hurt you later in the process. American companies thinking of taking the FDA's advice over the EMEA's after getting advice from both agencies should think again. "You're better off not taking their advice at all," says Kirke. "If you go to the EMEA for advice, you've got to take it."

Because of that, there are questions you should and shouldn't ask, and a correct way to ask those questions. Additionally, companies should seek out information on the experience and expertise within the agencies. "It's good to know which countries would have the experts on that product," explains Kirke. "It's to your advantage to try and get the people who do know about these products on board." You can find information on the agencies at the EMEA website or by consulting with the experts on the experts--consulting firms who know the agencies inside and out.

"Having said that, a well-funded agency is usually your best bet," Kirke adds. "You don't want to go somewhere where they don't have the resources to evaluate your product."

3. Maintain good documentation

Before meeting with a regulatory agency for scientific advice, you'll be required to submit questions and information on your work. Maintaining good documentation and producing quality reports in the early stages of drug development make things much easier and saves the company time and funds in the later stages. The most important thing a company can do towards this effort is to implement a system that facilitates the compilation of documentation.

Biotechs also need to make sure they are presenting the information according to industry standards. Some companies don't have any experience in the biotech industry and as such don't know how to write industry reports. "Sometimes they don't have reports at all, just data in lab books," says Kirke. But the type and style of information is very important. The way a report is written in the biotech industry is almost the opposite as what you produce in academia for a peer review publication or Ph.D thesis, Kirke explains. With an academic publication, you provide as much interpretation as possible, but you don't want to do this with an industry report as you can limit the amount of flexibility you have as you continue through the research and development of the product.

There are various templates available that you can use to keep track of your information. Companies don't necessarily need to outsource this, says Kirke. It's something biotechs can do themselves and it's cheaper to do this within the company, but for those that have a regulatory affairs representative on staff, it's a good idea to have them review the documentation. 

Building an EU regulatory strategy (2)

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