Regulatory Aspects of Personalised Medicines

The advent of big data analysis, genetic engineering and epigenetics has transformed the healthcare system by shifting the strategy for diagnosis, prevention and treatment of diseases from “one-size-fits-all” approach to “personalised” approach. Identification of biomarkers from molecular diagnosis has made tailoring of the medical treatment possible. Optimization of treatment decreases the costs related to the ineffective treatments and helps in avoiding possible side effects and adverse drug reactions. The efficient development of personalised medicine is largely dependent on the tools, sequencing techniques used and regulatory policies related to the personalised medicine products, tests and companion diagnostics. The uncertainties in the regulations governing personalised medicine should be eliminated and specific guidelines should be laid down by the respective regulatory authorities to bridge the emerging tools and technologies with the regulatory policies. Also, proper regulatory approval pathways for companion diagnostics will resolve the complications of organized development of therapeutic products and diagnostic tests.