Pharmaceutical Quality – Regulatory Collaboration Pilots: Call for Industry Applications

 

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.

What to submit?

Where to submit?

  • Send the completed form to the following mailbox addresses:
    icmra-pac-pilot[at]fda.hhs.gov
    icmra-pac-pilot[at]ema.europa.eu
    icmra-pac-pilot[at]pmda.go.jp
  • The application should be sent to each e-mail address using EudraLink. EudraLink is a secure file transfer application provided by EMA allowing drug companies and national medicine authorities to be able to exchange highly sensitive documentation with the highest level of security.
  • If an interested sponsor does not already have a EudraLink account then please first register for an EMA account following the instructions here; https://register.ema.europa.eu/identityiq/home.html.
  • Once an EMA account has been registered, the sponsor should request a Eudralink account via the EMA Service Desk:
    https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals

When to apply?

Interested sponsors can send completed application forms beginning 15 June 2022. The ICMRA Collaboration Pilots plan to conduct a rolling review of submitted applications, with the aim of starting the first pilot in the early September 2022 timeframe.

For further information contact: icmra-pac-pilot[at]fda.hhs.gov 

 

SUPPLEMENTARY INFORMATION

Background:  ICMRA recognizes that development, manufacture, and supply of medicines is now global, and a more global regulatory pharmaceutical 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.  

Further reliance among regulators for CMC review requires that the data for the same product, same facility(ies), and same change(s) be submitted in the same format [e.g., following harmonized standards specified in ICH M4Q, M8, etc.].  It also requires convergence of regulators’ specific data expectations for sponsor submissions, their standards for CMC related regulatory review, and their resulting assessments.

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)

It must also be noted that some outcomes cannot be achieved through this effort:

  • Harmonisation and the desired convergence cannot be achieved only through the few pilot cases.
  • Whilst the aspiration is to achieve a single outcome in each case, unless there are different regional legal/ regulatory requirements, the focus will be to pave the path for the future, rather than solely the case outcomes.
  • Each region is still bound to its existing regulatory and legal framework, and any differences cannot not be bridged through this pilot.

For more detailed information about each of these pilots please check the links below.