Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


PhRMA examining costs of converting NDAs to meet EU, Japanese requirements.

This article was originally published in The Tan Sheet

Executive Summary

PhRMA EXAMINING COSTS OF CONVERTING NDAs TO MEET EU AND JAPANESE STANDARDS to help justify its request for harmonized data submission requirements. In a May 9 letter to company regulatory affairs officials, the Pharmaceutical Research & Manufacturers of America noted that the International Conference on Harmonization steering committee has asked the association to conduct an industry survey in Japan, Europe and the U.S. "to quantify the resources, in terms of time and people, that are currently expended to rearrange, rewrite, reassemble, and otherwise customize a submission from one ICH region to another."





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts