Session A03: Hints and Tips for Acceptance of your Prescription Medicines Submission(s) Melissa Quinn B.Pharm (Hons) Director & Senior Pharmacist - Application Management & Exports Section Prescription Medicines Authorisation Branch Medicines Regulation Division Therapeutic Goods Administration ARCS 21 August 2018
Outline • Prescription Medicines: Regulation Basics • General Workflow for Screening Applications • The Registration Process • Legislative Basis for Applications • Application Categories • How to Submit Applications • Pre- application Activities • Focus on Category 1 Applications • Application Acceptance • Mandatory Requirements – Overview • Fees and Charges • So…What Goes Wrong? • How We Can Help • What is TGA Currently Working On? • Final Hints and Tips • Questions? 1
Some Stakeholder Management Things this presenter is not: An IT or legal expert! – When you encounter issues with forms or IT systems, please always give feedback so we can resolve as quickly as possible. – Resolutions for existing IT problems will not be provided in this talk but I am happy to take a list of questions on notice! – Many legislation related queries are very situation specific and the TGA generally cannot provide external stakeholders with legal advice, but can provide some direction/guidance when appropriate. – It is important for you to understand the relevant legislation and seek your own legal advice as required. 2
Prescription Medicines: Regulation Basics 3
Prescription Medicines Registration Pharmacovigilance and Special Access Branch Medicines Regulation Medical Devices & Scientific Laboratories Division Product Quality Division Evaluation Branch Branch Prescription PM Medicines Manufacturing Registration Authorisation Quality Branch Processes Branch Scheduling & Product Billing Committee & Industry Support Assistance Section Section Regulatory Practice & Support Division Pharmaceutical Benefits Division
Prescription Medicines Authorisation Branch Structure • The Prescription Medicines Authorisation Branch is comprised of 6 Clinical Evaluation Units (CEU). • Each unit is responsible for assessing prescription medicines applications within particular therapeutic areas. CEU 6 CEU 1 CEU 2 CEU 3 CEU 4 CEU 5 • Haematological • Analgesia • Cardiac disorders • Infectious diseases • Neoplastic disorders • Contraception disorders, including • Neurological disorders • Lipid disorders • Vaccination against infectious solid tumour oncology • Infertility o haematological hormonal effects of disease • Psychiatric/Psychological/ • Inherited metabolic o • Obesity malignancies functioning carcinoid Behavioural disorders disorders • Immunological disorders • Paget’s disease of bone neoplasms radiopharmaceuticals for o • Anaesthesia • Vascular disorders • Other Radiopharmaceuticals for cancer (therapeutic) o • Endocrine disorders • Musculoskeletal disorders • Gastrointestinal disorders radiological agents (e.g. contrast solid tumours (therapeutic) o • Other • Disorders of the female media) • Nutrition • Disorders of the male Surgical haemostasis o adjuncts to reproductive system o reproductive system • Disorders of the mouth (plasma products) radiopharmaceuticals and • Pregnancy and labour • Renal & urinary tract • Disorders of the skin contrast media use disorders • Fluid & electrolyte • Poisoning diagnostic tests for infections o • Disorders of the ear allergens (diagnostic or disorders Opioid antagonists o o therapeutic) • Poisoning • Disorders of the eye antivenenes o Heavy metal poisoning o • Respiratory disorders radiopharmaceuticals for cancer o Cyanide poisoning o (diagnostic) • Disorders of the nose, paranasal sinuses & upper airway Further information can be found in Guidance 4 of the Australian Guidelines for Prescription Medicines (ARGPM)
Branch Overview: Sections Application Entry, Support & Business Systems Review & Transparency Reforms & Application & Advisory Exports Reporting Evaluation Support Management Retrospective performance Application Entry Team External evaluator procurement Case Management reporting Application Support Team Reforms implementation Media and ministerial KPI reporting Exports enquiries Associated legislative and Sponsor Pipeline Reporting guidance change FOI requests Secretary of Advisory (Forecasting) Committee for Medicines aet.application.entry.team@health.gov.au Change management Business improvements and ast.application.support.team@health.gov.au International work-sharing solutions AusPAR preparation and publication eCTD reform Streamlined Submission Review B2B Portal Premier Replacement Pre-submission meetings streamlinedsubmission@health.gov.au
General workflow for screening applications Application received and application fees paid Date = 40 working day start Application screened by AESE (administrative) and assigned to a case manager for further technical screening Application has minor deficiencies Application has Deficiencies Deficiencies Application Opportunity to remedy minor critical issues/ resolved unresolved acceptable deficiencies unresolved deficiencies Notice of acceptance sent Notice of refusal sent 7 Payment of evaluation fees CMES
Evaluation: Key Phases Phase Description 1. Pre-submission Applicant provides necessary information on scope and scale of application. Assists resource planning 2. Submission TGA completes activities in preparation for application evaluation. Letter of application acceptance. NOTE: Application MUST be in the Form approved by the Secretary. 3. First round assessment Evaluators assess the dossier 4 Consolidated Section 31 requests TGA will consolidate all questions from evaluators and send to applicant. Stop Clock. Rolling questions used for Priority 5. Second round assessment TGA evaluators assess the application in view of the response to questions 6. Expert advisory review Delegate may seek independent advice after considering all evaluation reports 7 TGA Decision TGA delegate makes a decision 8. Post-decision Administrative and regulatory activities are completed 8
TGA clock in working days Designation Registration for decision timing ('Milestone 7') non-generic and for the different pathways provisional generic priority COR-A COR-B TGA clock application submitted STARTS STOP-CLOCK, − 40 dossier s.31 questions submitted 175 0 20 0 120 150 155 220 255 to sponsor Round 1 Round 2 evaluation evaluation orphan, MS5 MS6 legislated MS1 MS2 MS3 MS4 priority, timeframe (optional) (except for COR) provisional ACM (if required) expert advice (optional) MS7 TGA clock STOPS • Multiple submission pathways ranging from 120-220 target days to provide efficiencies in market approvals Priority Review (Jul 2017) = substantial evidence & complete data dossier Provisional Approval (Mar 2018) = early clinical safety & efficacy data Comparable Overseas Regulator (COR) report-based process (Jan 2018) 9
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The Registration Process A submission to register a new prescription medicine is supported by: 1. Quality data: for both the drug substances (drug master files etc.) and for the dosage form 2. Nonclinical data (if required) 3. Clinical data: might be evidence of bioavailability (i.e. the extent and rate of release from the dosage form: in vivo or sometime in vitro ) 4. Evidence of Good Manufacturing Practice is required. Data required outlined in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) 11
Applications • Set out in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 . – Section 9C – request for copy of ARTG entry – Section 9D – request to vary information about an ARTG entry – Section 14 – exemption from compliance with a standard – Section 23 – registration or listing (in this case each application results in a single registration or listing or inclusion of a separate and distinct product within a grouped registration or listing) – Section 61 (6) – request for information from ARTG – Regulation 14 – transfer of goods registered/listed – Regulation 14A – reassignment of registration/listing numbers 12
Application Categories • Regulations 16A to 16G, includes statutory processing times. • Category 1 applications: – An application for a new medicine or a change to a medicine constitutes a Category 1 application if it does not meet the requirements of Category 3 • Comparable Overseas Regulator (COR) report based process: – Implemented on 2 Jan 2018 as part of MMDR reforms – Builds on previous Category 2 process. • Category 3 applications: – Changes to quality data of a medicine already in the ARTG 13
How to Submit Applications • Obtain access to TGA Business Services www.tga.gov.au/tga-business-services. – Prescription medicines applications are lodged via the TBS portal. – Applicants need to be set up in the TGA client database in order to lodge applications. • Applicants should ensure their company generic email address has been added to the TGA client database. 14
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