艾昆玮-档案提交更新：马来西亚卫生部药品上市第三版的关键变化（英）

Updates for Dossier Submission: Key Changes in the 3rd Edition for Listing Medicines with the Malaysia Ministry of HealthSummary of ChangesC | Updates for Dossier Submission: Key Changes in the 3rd Edition for Listing Medicines with the Malaysia Ministry of HealthTable of contentsSummary of changes 1Listing workflow 2Types of dossier forms 3Email and mailing address 3Intention to submit 4Dossier formatting 6Dossier arrangement (hardcopy) 7Submission format (hardcopy vs. softcopy) 8Dossier D1 checklist and Dossier D1 form 8Dossier D2 checklist and Dossier D2 form 9Medicine price declaration form 9Applicant statement of declaration 9Supporting clinical evidence 10Supporting economic evidence 10Provision of one-year utilisation data post-listing 10Appendix: Workflow 11List of abbreviations 12Glossary 13References 14Authors 14About IQVIA Asia Pacific 14iqvia.com | 1iqvia.com | 1Summary of changes3Email and mailing addressChanges in address4Intention to submitNew instructions5Dossier formattingAdditional instructions6Dossier arrangement (hardcopy)New instructions7Submission format (hardcopy vs. softcopy) New instructions8Dossier D1 checklist and Dossier D1 formChanges in contents9Dossier D2 checklist and Dossier D2 formChanges in contents10Medicine price declaration formNo changes in content11Application statement of declarationAdditional clauses12Supporting clinical evidenceNo changes13Supporting economic evidence No changes14Provision of one-year utilisation data post-listingNew requirement15Appendix: WorkflowUpdates on duration of each processing stageNo.ItemChange1Listing workflowUpdates on duration of each processing stage2Type of dossier formsChanges in types of dossier forms2 | Updates for Dossier Submission: Key Changes in the 3rd Edition for Listing Medicines with the Malaysia Ministry of HealthListing workflow Updates on the duration of each processing stage• Specific timelines for each processing stage have been updated in the 3rd edition of the Guideline.2ND EDITION OF THE GUIDELINE3RD EDITION OF THE GUIDELINEDossier completeness screening timelineNot explicitly statedScreening for completeness of document to be completed within seven days of receiving documents from PRHBIA screening timelineNot explicitly statedScreening set at 90 working days, excluding stop clock for obtaining feedbacks from stakeholders and applicant.A maximum of three correspondence is allowed during screening• If BIA/CE is not satisfactory, a post submission meeting may be offered to discuss the issues involved• However, the dossier will be considered incomplete and will be rejected by the Secretariat if it is still not satisfactory• The applicant may need to resubmit the dossier after cooling-off period of three months along with previous comments and changes in the modelPayment timeline Payment to be made upon dossier submissionPayment to be made within 15 working days after date of screening approval (completeness of document and completion of BIA scr