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Pharmaceutical Quality – Regulatory Collaboration Pilots: Call for Industry Applications

Date:2022-07-10 Label: Source:管理员

SUMMARY

ICMRA is announcing the initiation of two regulatory collaboration pilots addressing facility inspections and Chemistry and Manufacturing Controls (CMC) and Post-Approval Change (PAC) submission assessments and related regulatory actions. The pilots are being operationalized under the auspices of ICMRA to explore the feasibility and potential for further collaboration and convergence among regulators in specific data expectations and assessment approaches when assessing manufacturing facilities for Pre-Approval and Pre-License Applications (PAIs & PLIs) and reviewing PACs and PAC Management Protocols.

The two pilots, one focused on collaborative assessments of CMC submissions, and the other on hybrid inspections, are to inform pre-market or PAC CMC assessment of drug applicants. Each of the pilots will involve two or more National Regulatory Authorities collaborating in the effort.  Please note that the actual post approval change submission should follow the normal regulations and procedures in each participating region.

Each pilot aims to conduct three assessments or collaborative hybrid inspections over an anticipated duration of 1-1.5 years, and then issue learnings and recommendations on how to operationalize these programs in the future to benefit Industry and Regulators. More information related to the vision, goals, and specific considerations for each of the pilots is provided the Supplementary Information section below.

Industry sponsors are invited to apply to participate in one or both collaboration pilots.


Who can apply?

Sponsors planning to file an application for a new product or for post approval changes of approved products to more than one Regulatory Agency. The proposal should focus on therapeutics (including both small molecule and biological products),which can include products intended for the treatment of patients with COVID-19, Breakthrough/PRIME/Sakigake,etc.products,or products deemed medically necessary/critical medicine.  The submission should be intended to be submitted to multiple regulatory authorities at the same time and should be provided to all participating regulatory authorities.

Sponsors intending to submit a proposal for the inspection pilot should confer with the management of the facility and ensure that the facility will be inspection ready and can host a collaborative hybrid inspection. The facility should satisfy themselves that they have appropriate IT infrastructure, availability of necessary interpretation service and can co-ordinate with at least two inspectorates across different time-zones. Please refer to the Application form for further detail on necessary requirements.

SUPPLEMENTARY INFORMATION
Background: 

ICMRA recognizes that development, manufacture, and supply of medicines is now global, and a more global regulatorypharmaceutical quality knowledge management (PQ KM) capability would improve regulators’ ability to readily share and utilize information that may already be received or collected.  This includes information on manufacturing facilities, products, marketing authorization applications and marketing application holders.  This PQ KM capability could support more streamlined regulatory assessment of facilities and of post-approval CMC changes and promote effective industry pharmaceutical quality management supporting both development of new medicines and continued availability of already approved critical medicines.

ICMRA began exploration of this with a July 2021 ICMRA-Industry workshop as part of a joint effort to expand availability of COVID-19 therapeutics and vaccines by increasing manufacturing capacity.  The ICMRA workshop highlighted the need for more convergence on CMC aspects between regions to allow faster supply of critical medicines to patients and the need to overcome travel logistical challenges created by the pandemic through use of hybrid inspections.  This identified need has motivated the planning of these two collaboration pilots.

In terms of the two focus areas these ICMRA collaboration pilots aim to achieve the following:
•Develop an initial common framework for collaborative assessment and hybrid inspections.
•Deliver a single list of questions to the sponsor or manufacturer wherever possible, and identify any misalignments, differences, and potential areas for alignment or harmonization across participating regulators’ regions.
•Share application sponsors’ or manufacturer responses between the participating quality assessors/inspectors who will work towards a common approach to assessment and decision making.
•Identify best practices and standards in the quality assessment of CMC post-approval changes and collaborative hybrid inspections to inform relevant quality assessments.
•Identify the conditions (products/ cases) where cross-regional collaboration efforts in the collaborative assessment and hybrid inspection pilots should focus and make recommendations to ICMRA for a future cross-regional pathway(s)

ICMRA Membership Country/Region and Regulatory Authority
•Australia:Therapeutic Goods Administration (TGA)
•Brazil:National Health Surveillance Agency (ANVISA)
•Canada:Health Products and Food Branch Health Canada (HPFB-HC)
•China:National Medical Products Administration (NMPA)
•European Union:European Commission Directorate-General for Health and Food Safety (DG SANTE)
•European Union:European Medicines Agency (EMA)
•France:National Agency for the Safety of Medicines and Health Products (ANSM)
•Germany:Paul-Ehrlich-Institut (PEI)
•Mexico:Federal Commission for Protection against Health Risks (COFEPRIS)
•India:Ministry of Health and Family Welfare (MoHFW)
•Ireland:Health Products Regulatory Authority (HPRA)
•Italy:Italian Medicines Agency (AIFA)
•Japan:Ministry of Health, Labour and Welfare (MHLW)
•Japan:Pharmaceuticals and Medical Devices Agency (PMDA)
•Republic of Korea:Ministry of Food and Drug Safety (MFDS)
•The Netherlands:Medicines Evaluation Board (CBG-MEB)
•New Zealand:New Zealand Medicines and Medical Devices Safety Authority (Medsafe)
•Nigeria:National Agency for Food and Drug Administration and Control (NAFDAC)
•Singapore:Health Sciences Authority, Singapore (HSA)
•South Africa:South African Health Products Regulatory Authority (SAHPRA)
•Sweden:Swedish Medicines Products Agency (MPA)
•Switzerland:Swissmedic
•UK:Medicines & Healthcare products Regulatory Agency (MHRA)
•US:Food and Drug Administration (FDA)

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