Formal health-authority meeting pathways compared: FDA, EMA, MHRA, Health Canada, PMDA and NMPA

Structured, fee-bearing dialogue with a regulator is one of the highest-leverage tools a development team has. A well-timed meeting can lock in an acceptable endpoint, settle a CMC comparability question, or confirm whether a dataset will support filing. But the six major agencies organise this dialogue very differently: some run a tightly codified menu of meeting "types" with legislated clocks (FDA, China's CDE), others a committee-driven scientific advice procedure that runs on monthly cycles (EMA), and others a more discretionary consultation model (Health Canada, PMDA). This overview maps the formal pathways side by side so a regulatory team can see, at a glance, what to request, when, and how fast a response should come.

At a glance

Agency	Core formal pathway(s)	How the menu is structured	Indicative clock
FDA (US)	Type A, Type B, Type B (End-of-Phase), Type C, Type D meetings; INTERACT	Fixed meeting "types" under the PDUFA meeting-management goals, each with legislated timelines ⁸⁹	Response to request in 14–21 days; meeting held in 30–75 days depending on type ⁸⁹
EMA (EU)	Scientific Advice / Protocol Assistance (via SAWP → CHMP); PRIME; ITF briefing meetings; pre-submission meetings	Committee-driven procedure run on monthly plenary cycles, plus early-dialogue schemes ¹²¹⁵⁶	Monthly cycle; discussion meeting typically the following month ¹²
MHRA (UK)	Scientific advice meetings; Integrated Scientific Advice (with NICE); ILAP; EAMS/PIM	Menu of advice services plus an innovation pathway; fee-based, SME waivers ⁵⁴⁵²⁵³	EAMS designation meeting normally within 6 weeks of request ⁵⁸
Health Canada	Pre-CTA consultation; pre-submission / pre-NDS meeting; NOC/c eligibility discussion	Discretionary meetings requested to a Directorate ⁴³⁴⁴	Info package 30 days pre-meeting; NOC/c eligibility decision in 10 working days ⁴³⁴²
PMDA (Japan)	Face-to-face advice (clinical-trial consultations by phase, plus pre-application and quality consultations)	Fee-scheduled consultation categories, preceded by a preliminary interview ⁶⁹⁷³⁷⁴	Schedule-adjustment window opens the first working day two months before the consultation month ⁷⁴
NMPA / CDE (China)	Communication meetings: Type I, Type II, Type III; milestone meetings (pre-IND, EOP1/EOP2, pre-NDA/BLA)	Three meeting classes plus development-milestone meetings; three delivery formats ¹⁸⁹¹²³¹²⁴	Meeting arranged within 3 / 10 / 20 working days of acceptance for Type I / II / III respectively ¹⁸⁹

The rest of this article works through each agency in turn, then draws out the practical differences a global program has to plan around.

FDA: a codified menu with legislated clocks

FDA's formal meetings for drug and biologic sponsors are defined in the PDUFA meeting-management goals, which fix both the meeting types and the clocks that go with them. There are five meeting types plus a pre-IND early-engagement option:

Type A meetings are for a stalled program that needs to proceed, or to address an important safety issue. FDA notifies the requester in writing within 14 days and the meeting is held within 30 days of the request ⁸⁹.
Type B meetings include the standard pre-IND and pre-NDA/BLA meetings. FDA responds within 21 days and holds the meeting within 60 days ⁸⁹.
Type B (End-of-Phase) meetings cover certain End-of-Phase 1 and End-of-Phase 2/pre-Phase 3 meetings. FDA responds within 14 days and holds the meeting within 70 days; preliminary responses to the sponsor's questions are due no later than 5 calendar days before the meeting ⁸⁹.
Type C meetings are any other meeting type. FDA responds within 21 days and holds the meeting within 75 days ⁸⁹.
Type D meetings, added in the more recent PDUFA cycle, are narrow-focus meetings on "often one, but typically not more than two issues and associated questions." The meeting is scheduled within 50 days of the request, with preliminary responses due no later than 5 days before the meeting ⁹⁵.
INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER/CDER products) is intended for novel questions and unique challenges in early development, before an IND is filed. FDA responds within 21 days and holds the meeting within 75 days, with preliminary responses due 5 days before ⁸⁹⁹⁵.

If a sponsor asks for a date later than the standard window, the meeting should occur within 14 days of the requested date ⁸⁹. FDA also tracks a written-response-only format as an alternative to a live meeting for several of the meeting types, and issues preliminary responses to the meeting package for Type B (EOP), Type D and INTERACT meetings ⁸⁹⁹³¹¹³. The defining feature of the US system is that these are statutory performance goals, so the clocks are predictable and FDA reports its performance against them.

EMA: a committee-run scientific advice procedure, plus early-dialogue schemes

EMA does not use a fixed "meeting type" menu. Its central formal offering is Scientific Advice, and, for designated orphan medicines, Protocol Assistance, which a sponsor can request at any stage of development ⁵³. The procedure is run through the Scientific Advice Working Party (SAWP), with PRAC involvement where safety studies are in scope; SAWP coordinators draft preliminary reports, and the final advice letter is adopted by the CHMP before it is issued to the applicant ⁶¹²³.

Mechanically, requests are submitted through the IRIS platform with a briefing document, a preparatory meeting with Agency staff can be arranged, and preliminary reports are discussed at SAWP and PRAC plenary meetings; if a list of issues is raised, a discussion meeting with the applicant and SAWP members is typically held the following month, after which SAWP issues a draft joint report and CHMP adopts the final advice ³⁴¹². The advice runs on EMA's monthly committee calendar. Notably, the source material does not state that EMA scientific advice is legally binding on the applicant or the Agency ¹².

EMA layers two early-dialogue mechanisms on top of formal advice:

The Innovation Task Force (ITF) is a free early forum, often the first contact point with EMA, for developers of innovative emerging therapies, methods, technologies and borderline products. ITF briefing meetings let developers discuss early ideas and identify scientific, legal and regulatory issues before they invest in formal scientific advice ¹⁶⁸¹⁶²¹⁷¹.
PRIME (PRIority MEdicines) supports medicines targeting unmet medical need. Eligibility follows the accelerated-assessment criteria (preliminary clinical evidence of significant benefit; SMEs and academics can enter earlier on compelling nonclinical and early tolerability data) ¹⁵⁸. On selection, EMA appoints a CHMP or CAT rapporteur, holds a multidisciplinary kick-off meeting to shape the development plan and regulatory strategy, gives scientific advice at key milestones, and assigns a dedicated contact point ¹⁵⁶¹⁵⁷¹⁵⁸.

Before an application, applicants also hold pre-submission meetings to settle procedural and regulatory questions so the dossier can be validated and processed promptly; EMA asks to be notified of upcoming submissions 6 to 12 months ahead for planning ²⁹³⁰.

MHRA: a services menu anchored by an innovation pathway

Post-Brexit, the UK runs its own suite of formal interactions. MHRA scientific advice meetings cover the full lifecycle, from CMC/biological process questions and bioequivalence design to reclassification, repurposing and complex combination products. Attendees and format are agreed in advance, meetings run up to 90 minutes, and written advice follows ⁵⁴. Requests require a completed form with a full list of questions (MHRA will not process a request until the question list is complete), the service is fee-bearing, and UK SMEs with MHRA-approved SME status may qualify for a fee waiver on the MHRA component ⁵⁶⁵².

Beyond standalone advice, MHRA offers:

Integrated Scientific Advice jointly with NICE, covering regulatory and HTA perspectives under a single fee; the company presents slides, the joint team reviews materials in advance, and the advice is treated as preliminary until the written report issues ⁵².
The Innovative Licensing and Access Pathway (ILAP), built around an Innovation Passport designation and a Target Development Profile (TDP) that creates a UK roadmap. ILAP has multiple entry points from non-clinical data onward and offers a toolkit including adaptive inspections, novel trial-design support, continuous benefit-risk assessment using real-world evidence, rolling review and accelerated marketing-authorisation timetables ⁵³⁵⁵.
The Early Access to Medicines Scheme (EAMS), whose Promising Innovative Medicine (PIM) designation step has a defined clock: the designation meeting is normally set within 6 weeks of the request, runs up to an hour, and the internal review group usually decides within 4 weeks of the meeting ⁵⁸.

MHRA's scientific advice service and innovation office are also offered as ongoing support even where an ILAP designation is unsuccessful ⁶¹.

Health Canada: discretionary meetings tied to submission milestones

Health Canada's formal meetings are requested to the relevant Directorate and are organised around submission milestones rather than a fixed type menu.

Pre-CTA consultation lets a sponsor present data and get guidance on the acceptability of proposed trials, and is especially useful for new active substances or novel issues. The sponsor submits a written request proposing four suitable dates with a study synopsis and preliminary questions; once agreed, the pre-CTA information package must be provided 30 days before the meeting, and the sponsor should send a written record of the discussion within 14 days afterward ⁴³⁴¹.
Pre-submission / pre-NDS (or pre-SNDS) meetings familiarise review staff with a pending submission, let the sponsor discuss areas of concern and potential Priority Review eligibility, and let the Directorate align resources; sponsors submit a pre-submission information package to the Submission Management Division in advance ⁴⁴.
During a pre-NDS/pre-SNDS meeting, Health Canada may also advise on Notice of Compliance with conditions (NOC/c) eligibility where evidence is promising but incomplete; if enough information is provided, the eligibility decision is rendered within 10 working days of finalising the meeting minutes ⁴².

The source material does not describe a distinct, separately branded "scientific advice" program at Health Canada beyond advice given within these meeting pathways ⁴²⁴⁴.

PMDA: a fee-scheduled consultation system with a mandatory pre-step

Japan's formal mechanism is the PMDA face-to-face advice system, a set of fee-scheduled consultation categories aligned to development stage:

Non-clinical (drug evaluation) consultations in toxicity, pharmacology and pharmacokinetics; Phase I and Phase II trial consultations; consultations before the start of expanded clinical trials; and pre-application consultations (including a pharmaceutical/quality preliminary evaluation and a rare-disease priority-review-eligibility consultation) ⁶⁹⁷⁴⁷¹.
The pre-application consultation is used when development is complete or nearly so, to advise on how to compile the application and whether the documents are sufficient ⁷¹.

A distinctive feature is the mandatory preliminary interview before the face-to-face advice: it clarifies scope and confirms the submitted materials, and for certain programs (for example, application data packages from investigator-initiated trials) a preliminary interview and meeting must occur before the schedule-adjustment request ⁷³⁷⁴. The applicant then files a "Request for Adjustment of the Schedule for Face-to-Face Advice." As a general rule the schedule-adjustment window opens from 10:00 to 16:00 on the first working day of the month two months before the consultation month, with tighter timing for some categories (for example, the Monday 5 weeks before the planned date for many clinical-trial consultations) ⁷⁴⁷². When multiple applications fall on one day, PMDA prioritises using a point method, with separate priority handling for Sakigake-designated drugs and orphan drugs eligible for priority review ⁷⁴.

The consultations carry substantial fees set out in a published schedule, for example a Phase I trial consultation at ¥5,505,400 and a Phase II trial consultation at ¥7,105,200, with lower fees for pre-application items such as the rare-disease priority-review-eligibility consultation (¥266,400) ⁶⁹.

NMPA / CDE (China): three meeting classes plus milestone meetings

China's CDE (under NMPA) runs a formal communication system with three meeting classes distinguished by urgency and stage, plus development-milestone meetings.

Type I meetings address urgent safety issues, breakthrough-therapy products, and other situations needing an immediate meeting; the meeting is arranged within 3 working days of CDE accepting the request ¹⁸⁹.
Type II meetings cover important milestones such as pre-IND and end-of-Phase 2 (EOP2), arranged within 10 working days of acceptance ¹⁸⁹.
Type III meetings cover later-stage, pre-submission interactions such as pre-NDA, arranged within 20 working days of acceptance ¹⁸⁹.

Separately, CDE frames its formal interactions around development milestones, encouraging pre-IND, Phase 1 completion (EOP1), Phase 2 completion (EOP2) and pre-NDA/BLA meetings; the pre-NDA/BLA meeting is used to discuss the planned application's format and content, labeling and risk management, dataset structure, acceptability of data and the projected submission date ¹²³¹²⁴. Feedback is delivered in one of three formats, face-to-face meetings, teleconferences, or written responses, and CDE maintains an "Applicant's Window" on its website for pre-submission consultation ¹²⁴¹²⁵. CDE guidance also directs sponsors to request milestone meetings only once development has progressed enough for a full discussion, and notes that detailed procedural timelines are elaborated in separate CDE measures that themselves reference the US PDUFA/BsUFA agreements ¹²⁴¹²³.

What actually differs, and why it matters for planning

Three structural differences drive most of the practical planning consequences:

Codified clocks versus discretionary scheduling. FDA and CDE publish meeting-type clocks, so a team can back-plan a filing timeline with confidence: an FDA Type B (EOP) meeting will be held within 70 days, a CDE Type II within 10 working days of acceptance ⁸⁹¹⁸⁹. EMA runs on a monthly committee cadence rather than a per-meeting clock, so timing is a function of the plenary calendar and how many issue rounds the SAWP raises ¹². Health Canada and PMDA are more discretionary, with the clock attaching to specific downstream steps (Health Canada's 30-day package deadline and 10-working-day NOC/c decision; PMDA's schedule-adjustment window two months out) rather than to the meeting itself ⁴³⁴²⁷⁴.
A single advice procedure versus a menu. EMA concentrates most formal input into one Scientific Advice / Protocol Assistance procedure, supplemented by ITF and PRIME for early and priority dialogue ⁵¹⁵⁶¹⁶⁸. FDA, CDE and PMDA instead offer a graded menu keyed to development stage (pre-IND through pre-application), which lets sponsors match the meeting to the decision at hand ⁸⁹¹⁸⁹⁶⁹. The UK sits between these, pairing a standalone advice service with the ILAP designation framework and an integrated MHRA/NICE route that folds HTA input into the same conversation ⁵³⁵².
Early, low-cost entry points. Several agencies now provide a free or low-friction first contact before formal advice: EMA's ITF, FDA's INTERACT (pre-IND), and CDE's Type I / Applicant's Window all let a developer test novel questions before committing to a full meeting package ¹⁶⁸⁹⁵¹⁸⁹¹²⁵. For a genuinely novel modality, these early touchpoints are often the most valuable and the least used.

For a global program, the sequencing implication is clear. FDA's legislated clocks and CDE's short acceptance-to-meeting windows make those interactions easy to place on a Gantt chart, whereas EMA scientific advice should be booked against the committee calendar well in advance and PMDA face-to-face advice against its two-month schedule-adjustment window. Whether the resulting advice is binding also varies and should not be assumed; the EMA material, for instance, does not characterise scientific advice as binding ¹². Teams running parallel filings should map each agency's earliest suitable entry point (INTERACT, ITF, CDE Type I/II) against their own data-readiness milestones rather than treating "a regulatory meeting" as a single, interchangeable event.

Formal Health-Authority Meeting Pathways Compared: FDA, EMA, MHRA, Health Canada, PMDA, and NMPA