TGA – GMP clearance information session GMP Clearance process Improvements Hongxia Jin & Stephen Farrell 5 th – 7 th September 2017
Welcome & Introduction Hongxia Jin – Director, Licensing & Certification section, Manufacturing Quality Branch Stephen Farrell – Assistant Director, Licensing & Certification section, Manufacturing Quality Branch 1
Agenda • GMP Clearance Overview - 30 minutes • GMP Clearance guidance - 45 minutes • Break - 15 minutes • Clearance Application Assistance Tool (CAAT) – 20 minutes • Redesigned e-form – 40 minutes • Sponsor responsibilities and CV Strategy – 15 minutes • Q&A Session – 15 minutes 2
GMP Clearance Overview • Approval and assessment of overseas manufacturers • History and background • Improvements made • Achievements to date • Current status 3
Approval of Medicine Manufacturers • All medicine manufacturers must receive an approval from the TGA before manufacture and supply, subject to exemption provisions and other requirements • Approvals – demonstrate compliance to the principles of Good Manufacturing practice – Australian manufacturers - GMP licence – Overseas manufacturers - GMP clearance to product sponsors • An application must be lodged via the TGA business portal (licence, GMP clearance or GMP certification) 4
Assessment of O/S Medicine Manufacturers GMP clearance • GMP Clearance process is a non-statutory mechanism used to verify that overseas manufacturing sites comply with the principles of good manufacturing practice • GMP clearances are required for the purpose of ARTG registration and listing, and continued supply once products are registered or listed • GMP clearances are granted to Australian sponsors for a specific time period • Two pathways to obtain a GMP clearance: – Desk top based assessment – TGA on-site inspection 5
GMP Clearance – Desk top assessment pathway • If current evidence is available from a recognised regulator using an equivalent standard and it covers the required scope, a GMP Clearance may be issued to the Australian sponsor via desk top assessment pathway • Evidence required will vary depending on the international agreements, location of the manufacturer, the competent authority and complexity of the manufacturing process – MRA assessment – Compliance verification (CV) assessment The TGA reserves the right to undertake an inspection of an overseas manufacturing site, irrespective of any other evidence supplied
GMP Clearance – Applications received annually 7,000 Number Of Applications 6,000 5,000 4,000 3,000 2,000 1,000 0 FY FY FY FY FY FY FY 10/11 11/12 12/13 13/14 14/15 15/16 16/17 Clearance Applications 2,418 3,900 3,941 4,222 4,048 5,657 6,506 Data taken on 03 July 2017 7
GMP Clearance - History Situation in late 2014 / early 2015: • Annual volume of GMP clearance applications received had increased • Backlog of all GMP clearance applications types (MRA & CV) • Backlog of emails (GMP clearance mailbox), requests to extend or transfer GMP clearances • MQB’s IT system (MIS) did not effectively capture application management information • Incomplete applications - evidence submitted with an application was not always complete/correct • Unable to raise online invoices for CV assessment fee 8
GMP Clearance – Improvements What we have improved to date: • Improved work management system (implemented in June 2015) allowing for improved data analysis • Updated internal guidance, work instructions and procedures • Engaged additional staff with appropriate skill set • Improved training processes 9
GMP Clearance – Improvements What we have improved to date: • Developed a forecasting tool for MRA applications to assist in managing processing times • Implemented a streamlined process for MRA applications (Implemented in March 2016) • Improved communication and transparency by providing regular updates to industry via the TGA website, email signature blocks and the TGA Business Services (tBS) portal 10
GMP Clearance - Achievements What we have accomplished to date: • Reduced response time for emails received via GMP Clearance mailbox: from >3 weeks to ≤ 5 days • Eliminated the MRA backlog of applications from 800 to on average ~130-200 • Reduced MRA processing timelines: from 18 weeks to ≤ 6 weeks 11
GMP Clearance - Achievements What we have accomplished to date: • Eliminated the backlog of GMP Clearance extension and transfer requests • Eliminated the backlog of applications awaiting to be receipted: from >500 in September 2016 to on average ~50 • Reduced the total number of GMP clearances in the system 12
GMP Clearance - Challenges • Incomplete CV applications or inadequate evidence • Inefficiency in processes: • Unable to raise online invoices for CV assessment fee • Multiple rounds of correspondence at receipt and assessment phase • Backlog of CV applications and long processing timelines 13
GMP Clearance – CV status Yet to be receipted 6% 6% Receipt In Progress 1% 10% 18% Awaiting Payment WOE Letters of Access to be processed 29% Yet to be assessed - 23% Total Assessment In 7% Progress - Total 14
GMP Clearance Process Improvements Current Initiatives GMP Clearance Guidance • clearly document requirements for GMP Clearance applications GMP Clearance Application Assistance Tool (CAAT) • web based assistance tool to assist applicants preparing GMP Clearance applications GMP Clearance Interim Solution • redesign of online GMP Clearance application forms Streamline receipt and assessment processes for CV applications 15
Questions? 16
GMP Clearance guidance revision 17 th edition (May 2011) Version 18 (Sep 2017) 17
GMP Clearance guidance revision Guidance revision topics • Aim of the revision • Industry consultation • Structure and readability • Step by step instruction • Commonly misunderstood information • Evidence requirements • Examples of specific evidence • Other evidence types 18
Aim of the revision • To improve the structure, readability and user experience • To clarify the most commonly misunderstood information • Address the most frequently asked questions • To provide clarification around the evidence requirements for different application types • To provide step by step instructions for preparing and submitting GMP clearance applications • To reflect our current practice 19
Industry consultation • Industry consultation was performed via the TGA Industry Working Group on GMP (TIWGG) and was conducted between March – May 2017 • The TIWGG is a consultative forum established in 2014 to facilitate consultation between TGA and industry 20
Industry consultation • The TIWGG comprises the following peak industry associations: – Accord – Australia New Zealand Industrial Gas Association (ANZIGA) – Active Pharmaceutical Ingredient Manufacturer’s Association of Australia (APIMAA) – Australian Self Medication Industry (ASMI) – Complementary Medicines Australia (CMA) – Generic and Biosimilar Medicines Association (GBMA) – Medicines Australia (MA). 21
Structure and readability • Removed duplicated information available elsewhere on the TGA website • Identified information that could be extracted into stand alone webpages. For example: – Responsibilities of Sponsors webpage – International agreements and arrangements for GMP clearance webpage • Structured the guidance into 3 distinct sections……. 22
Structure and readability Prior to Submitting your After submitting submitting your application your application application • Understanding your • Creating your • Application receipt supply chain and application • Application screening establishing • Selecting your scope • Application agreements • Providing your assessment • Identifying the evidence • Making a appropriate GMP • Submitting your determination and clearance pathway complete application assigning expiry • Identifying what and paying fees dates documentation is • Maintaining your required active GMP clearance 23
Step by step instruction The guidance will contain a step by step instructions for: • Creating your applications • Selecting your scope • Providing your evidence • Validating and submitting complete applications • Paying the required fees • Maintaining your active GMP clearances – Variations, renewals, extensions etc. • Transferring your GMP clearance applications 24
Commonly misunderstood information We aim to clarify commonly misunderstood information by providing: • Links to the relevant regulatory guidelines (i.e. ARGOM, ARGPM) for ease of reference • Contact information of the product regulatory areas to have a mechanism to check whether GMP clearance is required for the purpose of ARTG listing or registration. • Clarification around liaising including: – what evidence we can liaise for – what regulatory authorities we can liaise with – under what circumstances the liaising fee will be applied 25
Commonly misunderstood information We aim to clarify misunderstandings around the importance of knowing the details your supply chain 26
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