PLG as Interim Marketing Authorisation Holder

Although most blockbuster or novel treatments bear the label of one of the major global players, a great deal of innovation in the pharmaceutical industry comes from highly innovative, small and medium-sized enterprises (SMEs).

According to the EMA report on the 10th anniversary of their SME initiative in 2016 from all medicines by SMEs that were recommended for marketing authorisation between 2005-2015, about half contained a new active substance. A nature review of the pipeline of antibacterials, an area of growing interest due to the threat of increasing resistances, showed that 81% of preclinical projects in the antibacterial pipeline are in SMEs (Theuretzbacher, U., Outterson, K., Engel, A. et al. The global preclinical antibacterial pipeline. Nat Rev Microbiol 18, 275–285 (2020)).

Typically, the strength of those companies lies in their cutting-edge scientific expertise, often founded in their academic heritage or respective strategy of hiring world-class scientists. Equally typical, though, is their lack of regulatory personnel and know-how, in both, operational and strategic aspects. There are various strategies for SMEs when developing drugs, reaching from early collaboration with large partners – starting after proof of concept or even earlier – over buy-outs after milestones in clinical development to distribution and marketing agreements following approval. Depending on the specifics of those arrangements, the resources of the partner may be used to cover any gaps in expertise or workforce. However, the later such a partnership is formed, the higher one specific risk that is often underestimated: the need for a regulatory strategy as early as possible in development in order to avoid any pitfalls or dead ends and thus to decrease time to market significantly.

Once the development comes to its successful end; the authorities need to be convinced that the population will benefit from the authorisation to market of the new product in their jurisdictions.

ProductLife Group not only offers support throughout all phases of the development of a pharmaceutical product, but is also able to act as the applicant for a Marketing Authorisation Application in the EU on your behalf. All it takes is a Letter of Authorisation and while our experts provide you with consulting and hands-on support in preparing the required regulatory and scientific documentation, we will take care of all the administrative paperwork and communication involved in such a process.

And finally, after the approval by the regulatory agency (or agencies), when the launch of your product is imminent, we will hand over the function of the Marketing Authorisation Holder; either back to your company or to your partner, whatever you decided in your strategy.

In case of interest in this or any of our services, please feel free to contact us.