SOP: Health Authority Meeting Management (FDA Formal Meetings and EMA Scientific Advice)

This is a ready-to-use SOP. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows the template. Verify each cited regulation and guidance against the current source before you rely on it; meeting clocks and package timing are set by the user-fee program in force and change between cycles.

Document control header

1. Purpose

This procedure defines how <<FILL: COMPANY NAME>> plans, requests, prepares for, conducts, and closes formal interactions with health authorities, so that each interaction produces a clear, durable record the program can rely on and so that no commitment is made that the organization cannot deliver. It covers FDA formal meetings (Type A, B, B(EOP), C, D, and INTERACT) and EMA scientific advice and protocol assistance.

2. Scope

This procedure applies to all formal, scheduled, or written interactions with a health authority that produce an official record affecting a development program or marketing application, including pre-IND, end-of-phase, pre-submission, dispute, and CMC meetings, and EMA scientific advice, protocol assistance, and parallel consultation. It does not cover routine project-management correspondence with a regulatory project manager, day-to-day submissions, or inspection conduct, which are governed by <<FILL: SOP-IDs for submissions and inspection management>>.

3. Responsibilities

4. Definitions

• Meeting package / briefing document: the document submitted to the agency stating the product background, attendees, questions, and supporting data on which the agency forms preliminary positions.
• Preliminary responses: FDA’s written answers to the meeting questions, typically sent a few business days before the meeting.
• Official minutes: the agency-issued record of the meeting, which is the controlling record regardless of the sponsor’s own notes.
• Commitment: any action the sponsor agrees to perform, whether in the package, live, or in the minutes; tracked to closure.
• Serious determination terms (RTF, CRL, LoQ, LoOI, major objection): defined in the health authority interactions article; this SOP governs the meeting process around them.

5. Procedure

5.1 Decide the need and the type

1. Confirm the trigger: a development milestone, a specific scientific or CMC question, or a stalled / disputed program.
2. Map the trigger to the meeting type. For FDA: Type A for a stalled / disputed / post-RTF / post-CRL program; Type B for milestones (pre-IND, end-of-phase, pre-submission); Type B(EOP) for end-of-phase-2; Type D for one or two narrowly scoped questions; Type C for any other matter; INTERACT for novel modalities before pre-IND. For a clean question with a settled sponsor position, consider written responses only.
3. Record the decision and rationale in the interaction log (section 8).

5.2 Submit the meeting request

1. Prepare the request: product, application number, meeting type and format, purpose statement, preliminary questions, requested attendee disciplines on both sides, and proposed dates.
2. Route through the regulatory lead and obtain internal approval per <<FILL: approval matrix>>.
3. Submit and record the submission date and the acknowledgment.

5.3 Assemble and submit the meeting package

1. Build the package to the required structure: cover / application information; product development background and prior interactions; attendee list with disciplines; questions grouped by discipline, each with issue, sponsor position, and a closed ask; supporting data; tables, figures, references.
2. Each SME drafts its discipline section; the regulatory lead integrates; QA reviews every statement about validation, data integrity, GMP status, and inspection history for accuracy.
3. Confirm the package deadline for the meeting type against the current guidance (submitted with the request for some types, a set number of days before the meeting for others) and submit on time.
4. Run the package against the readiness checklist (<<FILL: checklist doc number, e.g. /templates/checklist-meeting-package-briefing-book>>) before release.

5.4 Handle preliminary responses

1. On receipt, distribute the agency’s preliminary responses to the team within <<FILL: number>> working day(s).
2. Re-plan the meeting around the disagreements; drop questions the agency has already resolved in writing.
3. If the preliminary responses resolve every question, decide whether to cancel the live meeting and accept the written responses as final; record the decision.

5.5 Prepare for and conduct the meeting

1. Hold an internal rehearsal: assign who answers each question, anticipate follow-ups, agree positions and fallbacks, and decide what may and may not be committed live and by whom.
2. At the meeting, keep to the disagreements, do not reopen settled questions, and do not commit to anything not pre-cleared. Defer anything uncertain to a written follow-up.
3. The note taker captures the discussion; the regulatory lead manages the agenda and the clock.

5.6 Reconcile minutes and capture commitments

1. Compare the agency’s official minutes against the sponsor’s notes within <<FILL: number>> working days of receipt.
2. Where the official minutes diverge materially or omit an agreement, request a correction through the regulatory project manager; record that the official minutes remain the controlling record.
3. Enter every agreement and action item into the commitment log (<<FILL: log doc number, e.g. /templates/log-health-authority-interaction-commitment>>) with an owner and a due date.

5.7 Execute and close commitments

1. Track each commitment to completion; QA owns any quality-system commitment.
2. Confirm delivery before the next interaction or the relevant submission; an undelivered commitment surfaces at the next milestone and at inspection.

6. Acceptance criteria

A managed interaction is acceptable when all of the following hold:

• The meeting type and format match the trigger, and the request and package were submitted complete and on time.
• Every question is framed as a closed ask, and every agency answer is captured (agree, disagree, or agree-with-conditions).
• No live commitment was made outside the pre-cleared set, and any deferred item was answered in writing.
• The official minutes were reconciled against sponsor notes, with corrections requested where needed, and every agreement and action item has an owner and a due date.
• Statements about validation, data integrity, GMP status, and inspection history in the package and responses are accurate and verifiable at inspection.

7. References

FDA Guidance for Industry, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (current PDUFA-cycle revision). 21 CFR 314.110 (complete response to a marketing application) and the parallel biologics provisions. Regulation (EC) No 726/2004 and EMA procedural guidance on scientific advice and protocol assistance. Regulation (EU) No 536/2014 (Clinical Trials Regulation), for EU trial-stage interactions. ICH M4 (eCTD / CTD) for the structure of supporting data.

Confirm the current version, clock, and package timing of each reference before issue.

8. Record generated: meeting record summary

9. Revision history

10. Approvals

Filled specimen

The following shows the meeting record summary completed for an example pre-BLA (Type B) meeting. The company, dates, and numbers are illustrative; replace them with your own.

In this example the team used written responses to resolve five of seven questions, held a short clarification call on the two CMC items, reconciled the minutes (catching an imprecise comparability statement and requesting a correction), and logged two commitments with owners and dates. That is what a controlled interaction looks like: durable record, no loose commitments, every agreement tracked.

Common inspection findings this SOP prevents

• A meeting agreement is referenced in a submission but cannot be located in any reconciled minutes or commitment record.
• A briefing package stated validation or comparability was complete when an inspection later showed it was not.
• Post-meeting commitments to the agency were never tracked and went undelivered.
• Information-request responses touching CMC or data integrity went out without QA review and created a new deficiency.

How to adapt this SOP

1. Set your document number, owner, and effective date in the header.
2. Point the cross-references in sections 5.3, 5.6, and 5.7 to your real readiness checklist and commitment log.
3. Insert your internal approval matrix for requests, packages, and live commitments.
4. Confirm the meeting clocks and package timing in section 5 against the user-fee program currently in force before issue.