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Regulatory reform

All things evolve to allow development, improvement and to ensure relevant change resulting in increased efficiency and optimisation. Regulatory affairs within the healthcare sector, seems also to conform to this law of nature.

As a key factor that dictates the fate of both novel and existing therapies from inception through to their release for use to patient populations, traditional practice within regulatory affairs has historically been an area of scrutiny.  The increasing pressure placed upon regulatory practices is sculpting certain trends and pathways resulting in more optimal processes.

One example of this is the use of a greater variety of alternative regulatory pathways in order to gain FDA approval, with advantages such as reduced time and costs of conducting studies. In general most drug approvals are grouped as follows:

  1. New Drug applications (NDA) – 505(b)(1) pathway
  2. Generic drug approval which references an approved NDA using an Abbreviated New Drug Application (ANDA) – 505(j) pathway
  3. OTC drug approved via reference of an existing monograph

A study by Thompson Reuters shows that the FDA is now reviewing significantly more drug applications for non- novel drugs made through the 505(b)(2) pathway than pathway 505(b)(1) used for New Drug Applications (NDAs), where previously the trend was in favour of the latter pathway. 505(b)(2) allows companies to gain approval of non-novel drugs that significantly differ from already approved counterparts without the need to replicate studies, but instead utilises data and literature already generated for the counterpart drug. In essence reducing the need for duplicated studies and also reduced data requirements for submissions.

A proposal for new legislations has recently come into play that would allow US patients to gain access to EU approved drugs. This would target a phenomenon known in the pharma industry as “drug lag” describing the time between approvals and marketing in one country and that for subsequent countries. Last year the FDA approved 66% of New Active Substances (NAS) quicker than other regulatory bodies from other countries, a consistent trend that has spanned that past 10 years. However a considerable proportion of new therapies are approved elsewhere including Europe. This has provoked a call for reform by some industry experts to allow the FDA to bypass approval delays caused by red tape, accelerating the process from a current 6 months to just 90 days. This would mean quicker release of new EU approved medicines to American patients and possibly vice versa in the future.

The plan is to increase harmonization and build on that already created by international groups such as International Conference on Harmonisation (ICH), this would allow a stronger convergence for regulatory standards across various bodies when governing risk and benefits for approving new drugs. In support of this are the EMA and HMA (Heads of Medicines Agency) who have released a united 5-year regulatory strategy that will govern and aims to overcome challenges specifically within human health, health in relation to veterinary medicines and finally that within the global regulatory environment.

Another positive example of change within the regulatory environment is the EMAs adaptive pathways pilot scheme, which is now entering its second stage of the trial and might be the answer to a more streamlined approval process. A change welcomed by both patients keen to access new treatments and the drug developers wanting their products to reach the market as soon as possible. The initiative aims to conduct small initial patient clinical trials for early approval, in order to release new drugs to select, restricted patient populations.

It is clear that regulators and drug developers’ gain to benefit from reform with the ultimate goal to increase collaboration and efficiency between regulatory agencies actively contribute to the global regulatory environment and finally ensure effective and optimal regulation of factors that impact human health.

Regulatory Affairs is a key function within the drug development process that underpins the safe release of new medicines to patient populations across the world. This is reflected by the ever growing need within the pharmaceutical industry for knowledgeable and experienced Regulatory Affairs professionals. I anticipate a good year for employees and professionals alike with an abundance of opportunity for growth and development.

If any professionals would like to discuss the market and their potential options further, or any companies would like a consultative discussion regarding the best way to build a strong talent pipeline in this rapidly changing market, feel free to get in touch on 0121 616 3405.


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11th May

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