​​​​​​​​​​​Resources


​Electronic Submissions Requirements​​:


                      Study Data Technical Conformance Guidance

                         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:

                        The next phase: Opportunities in China’s 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.