Inaugural Industry Forum on Good Manufacturing Practice - - PowerPoint PPT Presentation

Inaugural Industry Forum on Good Manufacturing Practice

Introductory remarks John Skerritt – 26 June 2018

This presentation

GMP is often seen as an “enabling function” but there was

• verwhelming interest in this meeting!
• Medicine and Medical Devices Review implementation
• SME Assist
• Other reforms to inspections and clearances
• Medicinal cannabis products
• International cooperation in brief

1

Medicines and Medical Devices Regulation Review

• The most extensive changes to TGA regulation in a generation
• Legislative changes in place, most business changes implemented
• Many reforms affect demand for/ timeframes for GMP:

§ Priority review § Provisional approvals § Comparable Overseas regulator approvals § Low-risk therapeutic goods § Sunscreen reforms

2

SME Assist

• Phone/ email support
• Training workshops
• SME-specific guidance documents
• Interactive decision trees
• Subscription services/ targeting
• Signposting to other services e.g.

international regulators, funding and business support, facility access, reimbursement

3

Other reforms: progress

• Risk-based approach to inspection frequency, re-inspection

frequencies and different product types introduced for medicines and blood, tissue and cellular therapies

• Increasing industry education and stakeholder engagement
• TGA-Industry technical working groups to finalise GMP

guidances

• Streamlining of internal business processes for GMP clearances

and compliance verification

4

Work in progress

• Sunscreens - aligning oversight to risk - PICS

interpretation, other inspection options, ingredient requirements

• Joint inspections with other regulators

§ Unclear what the implications of publication of

inspections findings ands conditions e.g. by Canada will be

• Fuller reliance on other countries for

clearances/ compliance verification

5

GMP fees and charges

• Changes to fees and charges for Australian and overseas

inspections from July 2018

• Lower fees for lower risk products/ more compliant manufacturers
• In order to reduce impact on industry, increases in GMP clearance

application / compliance verification fees will be implemented from July 2019

• A fairer charging scheme - but we will under-recover actual costs

until July 2019

6

GMP application to medicinal cannabis APIs

Type of manufacturing

The Code of GMP (Part II)

is applied to processes shown in bold

API extracted (plant) Collection of plants Cutting/initial extraction(s) Introduce the API starting material Isolate and purify Process and pack Herbal extracts (used as API) Collection of plants Cutting/initial extraction(s) Further extract Process and pack API powdered herbs Collection of plants and/or cultivation and harvesting Cutting and commuting Process and pack

7

“ “ if a sy syst stem, ser service e or p product h has s been been appro roved u under r a trusted i interna nationa nal stand ndard

• r

r ri risk a assessment, t the hen o n our re ur regulators sho hould no not impose an any ad y additional al r requirements f for ap approval in n Aus ustralia, unl , unless i it can n be demonstrated t tha hat there i is a goo

• od r

reason t to

• do
• so”
• ”.

In Australia, international regulatory cooperation is also official Government policy

Prime Minister’s media release 14 October 2014

International Coalition of Medicines Regulatory Authorities

Policy dialogue at agency head level (23 countries, EMA, EU and WHO) Initial projects completed:

• Generic medicines information sharing processes
• Documentation of capacity building initiatives
• Establishment of systems to support GMP Inspection reports from one

regulator to be recognised by other regulators – now PIC/S process Projects underway

• Pharmacovigilance – big data, enhancing HCP reporting, vaccines
• Supply chain security and crisis management
• Innovation and horizon scanning – new regulatory pathways

• Common template and safety assessment of 10 complementary

medicine ingredients, starting cooperation on efficacy/claims

• First work sharing trial for a generic medicine completed, along with

convergence of technical requirements e.g. bioequivalence

• Work sharing on New Chemical Entity submissions underway,

biosimilars cooperation being considered

• Synchronising submissions by industry to different countries is hard
• Secure portal for confidential information exchange developed

Implementation of work sharing on evaluating new medicines

Pharmaceutical Inspection Convention/Co-operation Scheme

• Development and maintenance of harmonised

GMP standards and quality systems for medicines inspectorates

• Use of GMP clearances based on reports

from recent inspection by other regulators reduces the number of TGA overseas inspections required by 90%

• Need to further develop process to see what

third country inspections we can recognise and

• btain GMP inspection plans

Conclusions

• Manufacturing quality is a central part of TGA’s regulatory system
• So impacts on GMP processes and demand need to be closely considered in

implementing reforms to medicines regulation

• Further business improvements underway
• International regulatory collaboration will provide benefits for
• industry – faster market access, lower costs
• earlier patient access to medicines
• regulators – reduced workload, less duplication
• Can make even greater use of inspections done by other regulators

(but Australia has to contribute to the global inspection effort!)

• Stronger communication and partnering with industry will be critical