1. India is considering a proposal to amend Rule 122(E) of the Drugs and Cosmetics Act to include products with new drug delivery systems (such as time-release, modified release, etc.) under the “new drug” category. From a practical standpoint what this means is that drug makers who launch differentiated products using such new drug delivery systems may not be able to bypass clinical trials and additional regulatory monitoring. This may delay launches and increase drug development costs for those pharmaceutical companies using these new delivery systems. To learn more, click here.
2. An interesting article published in the Journal of Market Access & Health Policy in November 2013 compared the performance of new molecule (NM) launches in the United States (US), European Union (EU) and Turkey between 2007-2013. The article reports that of the 183 NMs launched in the EU, US or both, only 44 (24%) were launched in Turkey. Of these 44 NMs, 34 received official reimbursement approval. Additionally, the difference in launch dates between the EU or US and Turkey was a mean delay of 821 days (2.25 years). The article can be found here: MTURKEYUSEU