Overview of TGA’s Involvement in the International Regulatory Environment Jenny Hantzinikolas Director, Inspections Section , Manufacturing Quality Branch Medical Devices and Product Quality Division, TGA GMP Forum - 26 June 2018
Overview • International Harmonisation • PIC/S activities 1
International Harmonisation International harmonisation of standards and inspections allows for a shared workload with regulators in other countries. 2
International Harmonisation We have been doing this via: • joint inspections with overseas partners • shared inspection scheduling • sharing of information - reports and manufacturer information • Mutual recognition of codes of GMP and standards 3
International Harmonisation It is made difficult by: • different regulations on the standards expected in different countries • different powers in the ability of regulators to access sites • sharing information and what information is allowed to be shared between countries 4
International Harmonisation TGA involvement includes • PIC/S reassessments of existing PIC/S members • Assessments of proposed PIC/S members • Joint inspections with MHRA, USFDA, Health Canada, HPRA • Shared information under confidentiality agreements with PIC/S members 5
International Harmonisation • TGA has provided training to various regulatory agencies e.g. Medsafe, ThaiFDA and USFDA. • TGA successfully hosted the Expert Circle on APIs in 2017 • TGA has been involved in PIC/S drafting groups 6
International Harmonisation • Inspector working group involvement in EMA • Reviews and inputs into revisions developed for PIC/S Guide to GMP 7
What is PIC/S? • A non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. • It is open to any Authority having a comparable GMP inspection system. 8
PIC/S update On 1 January 2018, PIC/S comprised 52 Participating Authorities from all continents. 9
PIC/S PIC/S’ mission is “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products”. 10
PIC/S Achieving this mission by • Harmonising inspection procedures worldwide, by developing common standards in the field of GMP, • providing training opportunities to inspectors facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. 11
PIC/S committee structure 12
An insight into PIC/S activities 13
Sub-Committee on the Harmonisation of GM(D)P (SCH) The mandate of the Sub-Committee is • to harmonise GMP, establish best inspection practices and • harmonise the interpretation of GMP to ensure consistency in inspection / audit practices. 14
Sub-Committee on the Harmonisation of GM(D)P (SCH) • The TGA is the deputy chair and EMA IWG liaison • Revision of PICS chapters /annexes and guidance is discussed/approved at the subcommittee • Updates on working group mandate is provided • Decisions are made on the way forward 15
Sub-Committee on Budget, Risk & Audit (SCB) • The TGA is member • Assess regulatory risk, financial risk, reputational risk and risk management and make proposals / recommendation to minimize such risk • Establish a budget proposal to the PIC/S Committee • Maintain internal financial control and examine financial transactions 16
Data Integrity TGA is a co chair of the working group • The working group has developed a PIC/S data integrity guidance document for inspectors to provide them with the basic skills for performing data integrity inspections. 17
Data Integrity The Working Group has also developed other data integrity guidance tools for inspectors such as an aide-memoire, flowchart to assist inspectors, and system specific guidance. 18
Harmonisation of the classification of deficiencies • TGA is the Chair • The working group has drafted a guidance document, which includes a tool for Inspectorates to improve harmonised risk classification of GMP deficiencies. 19
Harmonisation of the classification of deficiencies • Recommendations to facilitate harmonised compliance and enforcement approaches to address GMP non-compliance are also included. 20
Working Group on Annex 1 / Sterile Manufacturing • TGA is a member of this working group • Update to the Annex 1 to include up to date processes and technologies • Currently all comments from the public consultation are being reviewed by the working group. 21
Working Group on Annex 2 / Biologics & ATMP • TGA is the Chair of this working group • Update to the Annex 2 and creation of a dedicated Annex for ATMP • Identify areas of GMP applicable to ATMP that may benefit from modernization to reflect the current status of the manufacturing processes and manufacturing settings 22
Expert Circle on APIs • TGA is a co chair of this working group • Provides training to regulators through its seminars • Update to guidance as required 23
Expert Circle on Human Blood, Tissues, Cells and ATMPs • TGA is a member of the coordinating committee of this working group • Provides training to regulators through its seminars • The Expert Circle is developing a number of PIC/S guidance documents 24
Cross contamination in shared facilities • TGA is a member of this working group • Developed an Aide Memoire to – harmonise and standardise terminology used in relation with the control of cross-contamination in shared facilities. – address questions which inspectors should ask themselves during inspections in particular in relation with risk management. 25
Other PIC/S activities TGA is also involved in § The drafting of the new ATMP annex § The drafting of the product defect and adverse event procedure 26
Other PIC/S activities TGA is also involved in § Travel security working group § Automated systems working group § Good Clinical Practice working group 27
Summary This has been a snapshot of what the TGA is involved in terms of international harmonisation inclusive of some of the PIC/S activities. 28
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