Oncology Drugs: Evolution, Comparative study of Global Drug Regulatory approval process and various measures to improve availability and accessibility

  • Shagun Sharma
  • Khushbu Sharma
  • Pooja Verma
  • Shivali Rahi
  • Arpana Rana


Cancer is the leading cause of death worldwide and is a well-known fact that it can be cured if detected and treated early. Cancer treatment has evolved from conventional therapies like vinca alkaloids, photodynamic and radiation therapy, chemotherapy to immunotherapy. Recent advances in tumour agnostic therapies based on cancer genetics and molecular features has led to a single drug treating different types of cancers. Next Generation sequencing (NGS) represents an effective way to gather large amount of genomic information about a cancer. The concept of precision medicine goes along with an understanding of the cancer genome as determined by NGS. Thus with an array of cancer diagnosis and treatment options the marketing approval process globally is challenging. This is mainly due to lack of harmonization of guidelines. This review evaluates the approval process of oncology drugs in US, EU and India.  Recent USFDA initiatives like Project Orbis involving multi country collaboration and real time oncology review while EU PRIME and WHO proposed reliance pathway are several global initiatives which accelerates assessment process.

New NDCT rules introduced in India in 2019 is one of the key step towards faster availability and accessibility of Cancer drugs in the country.

Countries with high resource settings like USA and EU have recognized this and have made several initiatives to provide early access to patients. USA has several pathways for speeding up the regulatory approval process for oncology drugs. India has recently came up with New Drugs and Clinical Trial rules, 2019 (NDCT rules 2019) which laid down the provisions of Provisions of Accelerated approval, Expedited review and Clinical trial waivers ensures faster availability and accessibility  of  cancer drugs in the country.

Although a lot of initiatives have already been taken in this direction still there is a strong need to harmonize the requirements globally for faster availability and accessibility of drug in the country for the much-needed patients.

Keywords: Regulatory approval, FDA, NDCT rules 2019, Oncology Drugs, Next-generation sequencing (NGS), Oncology Center of Excellence (OCE), Real-Time Oncology Review (RTOR), USFDA, CDSCO


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How to Cite
Sharma, S., K. Sharma, P. Verma, S. Rahi, and A. Rana. “Oncology Drugs: Evolution, Comparative Study of Global Drug Regulatory Approval Process and Various Measures to Improve Availability and Accessibility”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 2, June 2022, pp. 102-11, doi:10.22270/ijdra.v10i2.542.