Electronic Submissions Requirements:
In June 2015, the FDA published the Guide to provide “technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs.”
Guidance for Industry - Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
In May 2015, the FDA said it would begin requiring electronic NDA, ANDA, BLA, and Master Files submission starting on May 15th of 2017 and Commercial IND starting on May 15th of 2018.
Clinical Bridging Studies:
Guidance for Industry E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers
In Sept, 2006 - the FDA published the Guidance “to provide answers to questions that have arose since the implementation of the E5 guidance in June 1998.”
Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials
In Sept, 2005 - the FDA published the Guidance for “sponsors of NDAs to include summaries of effectiveness and safety data for Important demographic subgroups, including racial subgroups. This guidance is also intended to help applicants in preparing biologics license applications (BLAs).”
China Pharmaceutical Market:
By 2016 it is projected that the pharmaceutical market in China will top that of Japan and therefore will become the second largest pharmaceutical market in the world.