Transatlantic integration a necessity

How likely is it that international regulators will agree to an integrated drug approval process?

Speaking exclusively to Pharmaceutical Technology Europe (PTE), Findlay explained that approval process synchronization would help streamline regulatory costs and prevent drug launch delays. "Transatlantic regulatory convergence will have immense benefits such as faster technology transfer, the harmonization of patent laws and pausing the regulatory approval of unsafe drugs," said Findlay. "This will ensure a faster approval process and enable new drugs to reach the entire medical community faster."

But it is not just transatlantic integration that is required; there is also a large amount of diversity between EU member states, although efforts have been made to harmonize regulatory procedures. "This was partly achieved by the introduction of a centralized procedure and mutual recognition procedures," Findlay explained. "However, there still lies a major gap between the regulatory authorities and the national pricing authorities." Centralized procedures authorizing the sale of drugs in all member states do exist, but companies still need to file for price on reimbursement approvals, which affects the launch timing of new drugs and influences parallel trading.

Despite the positive progress that has already been made towards transatlantic integration, however, will it ever fully be realized? An online survey conducted by PTE revealed that people were very unsure about whether regulators would ever agree to an integrated drug approval process; 32% of respondents said it was unlikely, but 45% believed it was possible. Findlay, herself, seems confident that integration will occur. "The formation of a common transatlantic regulation is quite near," she said. "As the pharma industry is moving towards globalization, regulatory convergence is critical."

The full interview with Sylvia Findlay can be read at: http://www.ptemag.com/findlay