Helping the pharmaceutical sector with the regulatory submission process

CLA’s Commercial Operations Manager, Andy Greenan, looks at why a CLA Pharmaceutical Licence is invaluable for any company developing a new drug.

When I’m talking to CLA clients in the pharmaceutical sector, it is clear that one of the most complex and lengthy processes they have to go through is regulatory submission. For those of you who don’t know their way around this often labyrinthine procedure, regulatory submission involves providing a regulatory agency (such as the UK’s Medicines & Healthcare Products Regulatory Agency) with detailed information about a new drug (or other medical advance) to prove that it is being developed in compliance with regulations and that it is ultimately efficacious and safe for human use.

Regulatory submissions are carried out at many stages throughout the research and development cycle and can continue on while a drug is in use. The development of medicines can take many years and generate hundreds of thousands of pages of information (for example, the results of long-term clinical trials). It is therefore no surprise that the regulatory submission process is a key challenge for the sector, with dedicated professionals employed to undertake the job of drawing together the information required.

Obviously, the process throws up a number of content licensing questions. For example: ‘Can I send third-party material as part of my submission without infringing copyright?’ The good news is that the CLA’s Pharmaceutical Licence covers a wide variety of content that is often sent to external organisations for the purposes of regulatory or patent submissions. It allows licensees to send copies of extracts, subject to certain terms and conditions, from books, magazines, journals and periodicals published in print and from a wide range of digital publications.

The licence states: ‘You may send digital or paper copies to the regulatory authorities in any jurisdiction. You may also send them to external regulatory advisers in connection with an application or regulatory advice.’

To ensure that the licence is fit-for-purpose, it was drawn up in close consultation with the Association of the British Pharmaceutical Industry (ABPI), which ‘works in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines.’

One key thing to note is that under the CLA Licence terms and conditions, the licensee must own or subscribe to the publication from which they wish to copy, with the exception of free-to-view material. To put it simply, suitable source copies are publications (print or digital) that are owned or subscribed to by the organization that takes out the licence.

One of the key developments in the world of regulatory submissions has been the move towards the use of electronic formats to send submissions and supporting information. The CLA’s Pharmaceutical Licence covers this aspect – allowing the copying of digital content, e.g. e-books, PDF files from electronic subscriptions, scanned articles circulated by email, online journal articles and certain website material.

Whether relating to hard copies or digital material, the Pharmaceutical Licence is a boon to professionals working in what is one of the world’s most heavily regulated industries.

With the above in mind, you may wish to apply for a CLA Licence or you may want further information to establish if a licence is required, if this is the case, please use the button below to contact us or call us on 020 7400 3171.  

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