Redica 监管回顾：2026 年 8 月（FDA CGT 指南定稿与 AI 器械框架草案等）

The month of August has proven relatively quiet, with fewer than 600 documents published for the month’s total, well short of a typical month’s volume. Three of the twelve topics that did surface come from cell and gene therapy, split evenly between the US and China: FDA finalized its CGT FAQ guidance and drafted a first-of-its-kind potency framework for active immunotherapies, while China’s CDE opened a dedicated PIONEER support track for CGT developers. A second cluster governs device software as it keeps changing after clearance, spanning FDA’s generative-AI discussion paper, IMDRF’s newly finalized predetermined-change-control-plan principles, and China’s first BCI technical-review framework. Despite the low volume of documents this month, CGT sponsors and adaptive-device developers still have real filing and validation strategy to revisit.

1. FDA Opens Foundational Discussion on Regulating Generative AI- Enabled Medical Devices FDA's Digital Health Center of Excelle

‍Draft | AI-Enabled Devices

FDA's Digital Health Center of Excellence proposes a two-axis risk framework and competency-based premarket model for GenAI devices. Comments close October 19, 2026.

Substance

The discussion paper, issued by CDRH's Digital Health Center of Excellence, proposes a two-axis risk-assessment framework to stratify generative-AI-enabled devices, one axis scoring how independently a function acts and the other scoring the consequence of relying on an incorrect output, with evidence expectations scaling with position on the grid rather than with the mere presence of a large language model. It proposes a competency-based premarket evaluation model drawing conceptual parallels to physician credentialing, combining non-clinical benchmarking with clinical confirmation, and describes risk-proportionate postmarket monitoring for foundation models and agentic AI systems, posing 26 numbered discussion questions rather than binding requirements.

Significance

This is FDA's first framework-specific document for generative AI in medical devices, distinct from its general AI/ML device guidance, and it drew same-day analysis from multiple law firms and a parallel citizen petition asking FDA to clarify AI vision-language-model classification signals before the comment period even closed; positions submitted now are likely to shape whatever binding guidance or rulemaking follows.

Redica Recommendation

Device manufacturers developing generative-AI-enabled products, particularly those built on foundation models or agentic architectures, should submit comments before October 19, 2026, since early positioning is likely to influence the framework's eventual binding form.

Reference document: Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

2. FDA Revises Its Foundational ANDA-vs-505(b)(2) Pathway Guidance for the First Time Since 2019

Draft | Generic Drugs

FDA's first update to its core pathway-selection guidance in seven years adds duplicate-drug and multiple-strength provisions. Comments close October 19, 2026.

Substance

The revised guidance, replacing its May 2019 version, adds detailed direction on when a 505(b)(2) application will be refused because the proposed product duplicates a listed drug eligible under section 505(j), clarifies that a pending 505(b)(2) application need not be withdrawn if a duplicate is approved first, and addresses situations where bioequivalence studies cannot be conducted because both the reference listed drug and reference standard appear on the Discontinued Drug Product List. It confirms that an applicant with multiple strengths, only some of which duplicate a listed drug, may file one 505(b)(2) application covering all strengths rather than splitting the submission.

Significance

This is the foundational guidance nearly every generic or hybrid-pathway sponsor uses to decide which application type to file, and it had gone unrevised for seven years; RAPS, Mondaq, and regulatory consultancies flagged the multiple-strengths clarification specifically as removing a real filing-cost duplication that previously required two separate applications for one product family.

Redica Recommendation

Sponsors preparing an ANDA or 505(b)(2) filing should re-run their pathway determination against this revised guidance before submission, particularly the duplicate-drug and multiple-strengths provisions, and submit comments before October 19, 2026 if the discontinued-reference-standard scenario affects a product in development.

Reference document: Determining Whether to Submit an ANDA or a 505(b)(2) Application - Draft Guidance for Industry - August 2026

3. IMDRF Finalizes Essential Principles for Predetermined Change Control Plans

‍Final | AI/ML Devices

IMDRF's finalized technical document gives regulators worldwide a common framework for adopting PCCPs. Published August 6, 2026.

Substance

The finalized IMDRF technical document sets out high-level principles for using predetermined change control plans to authorize planned medical device software modifications that would otherwise require new regulatory submissions, and identifies the elements manufacturers should consider when developing and documenting a PCCP, including limiting changes to the device's intended use, taking a risk-based approach, and using an evidence-based methodology. The framework is broad rather than prescriptive, allowing each jurisdiction to apply the concepts within its own existing regulatory scope.

Significance

RAPS and device-industry trade press covered the finalization closely, noting it follows the FDA's own statutory PCCP authority under the 2022 FDORA and gives regulators elsewhere, including the EU as it revises MDR and IVDR, a common reference point for building their own PCCP frameworks rather than developing incompatible national approaches independently.

Redica Recommendation

xManufacturers of adaptive or AI/ML-enabled device software should map their change- management documentation against this framework's essential principles now, since regulators building new national PCCP pathways are likely to reference it as the common baseline.

Reference document: Essential Principles and Content of Predetermined Change Control Plans

4. China Sets Its First Technical Review Framework for Implantable Brain-Computer Interfaces

Draft | Neurotechnology

CMDE's draft covers full electrode, decoding, and actuator characterization for Class III motor-function BCI implants. Comment period closes September 7, 2026.

Substance

The draft sets technical review expectations for Class III implantable brain-computer interface devices that decode movement intent from brain signals to control an actuating device, covering full characterization of electrodes, decoding hardware and software, and actuating components; system-level verification of electrical, mechanical, thermal, biological, wireless-power, cybersecurity, and reliability performance; and detailed validation of decoding algorithms, including dataset quality, generalizability, and controls for declining algorithm performance over time.

Significance

This is China's first dedicated technical-review framework for the device category, arriving five months after NMPA's approval of Neuracle's NEO system as the world's first commercially cleared invasive BCI, and law-firm and trade coverage frame it as following the same pattern China used for implantable neurostimulators, converting an ad hoc innovative-device review into a codified standard other applicants can build against; it also sits inside a national strategic push targeting a full domestic BCI supply chain by 2030.

Redica Recommendation

Manufacturers developing implantable BCI devices for the China market should map their decoding-algorithm validation and chronic-use safety data against this framework now, particularly the controls for declining algorithm performance, and submit comments before September 7, 2026.

‍Reference document: Key Points for Technical Review of Implantable Brain–Computer Interface Medical Devices for Motor Function Compensation (Draft for Public Comment)

5. FDA Finalizes Its Cell and Gene Therapy FAQ Guidance, Fulfilling a PDUFA VII Commitment

Final | Cell & Gene Therapy

FDA's 36-question FAQ guidance finalizes with new NAMs terminology not in the 2024 draft. Finalized August 20, 2026.

Substance

The finalized guidance answers frequently asked questions spanning regulatory review, chemistry/manufacturing/controls, pharmacology/toxicology, clinical, and clinical pharmacology considerations for cellular and gene therapy product development, moving with limited change from its November 2024 draft. One notable addition addresses New Approach Methodologies and the 3Rs principles for nonclinical animal-species selection, a topic the draft did not cover, and the guidance clarifies the distinction between INTERACT meetings and pre-IND meetings for novel development programs.

Significance

The finalization fulfills a Prescription Drug User Fee Act VII commitment to improve CGT development efficiency, and RAPS, Mondaq, and Big Molecule Watch all covered it within days, framing it as converting a proposal sponsors could previously treat as informal into FDA's current, citable thinking for immediate use.

Redica Recommendation

CGT sponsors relying on the 2024 draft's assumptions should reconcile internal templates against the finalized text, particularly the new NAMs-related nonclinical species-selection language and the INTERACT-versus-pre-IND meeting clarification.

‍Reference document: Frequently Asked Questions - Developing Potential Cellular and Gene Therapy Products - Guidance for Industry - August 2026

6. China's CDE Opens Its PIONEER Program, a Dedicated Support Track for Cell and Gene Therapy Drugs

Draft | Cell & Gene Therapy

CDE's draft PIONEER Program offers cell and gene therapy developers a capped, lifecycle regulatory support track. Comment period closes September 19, 2026.

Substance

CDE's draft PIONEER Program (先锐计划) establishes a lifecycle regulatory support track for eligible cell and gene therapy drugs, requiring applicants to submit a companion development plan covering mechanism, manufacturing controls, nonclinical evidence, and clinical trial sequencing; the companion draft on the program itself caps enrollment at 15 products a year and grants enrolled products Category I communication meetings at key milestones, pre-acceptance services, and a shortened supplementary-review timeline for qualifying manufacturing changes.

Significance

Trade coverage frames the program as building on CDE's broader PIONEER framework and China's 2024 State Council measures accelerating innovative drug development, positioning China's dedicated CGT support track as a counterpart to accelerated pathways already operating at FDA and EMA; the initiative also arrives as China's CGT sector faces fresh scrutiny following recent investigator- initiated-trial safety disclosures, giving the program's more structured, CDE-supervised track added significance as an alternative to looser investigator-led pathways.

Redica Recommendation

Sponsors developing innovative cell and gene therapy products for the China market should prepare a PIONEER-compliant development plan now and request a Category I communication meeting early, since the program's annual cap rewards early, well-documented applications, and should submit comments before September 19, 2026.

Reference documents: Cell and Gene Therapy Drug Development Plan (Draft for Comments), "Pioneer Program" for Cell and Gene Therapy Drugs (Draft for Comments)

7. FDA Drafts Its First Potency Framework Built Specifically for Active Immunotherapy Products

Draft | Cell & Gene Therapy

FDA's draft closes a potency-assay gap for ACTIMPs that fall outside its existing CGT framework. Comments close November 18, 2026.

Substance

The draft guidance recommends linking each active immunotherapy product's mechanism of action to potency-related critical quality attributes and using quantitative assays capable of distinguishing acceptable lots from subpotent ones, describing an iterative potency- assurance approach spanning development through licensure. It provides distinct approaches for peptide- and protein-based, vectored, personalized, and cell-based active immunotherapies, distinguishing biological from physicochemical assay methods and setting expectations for investigational-stage identity, quality, purity, strength, and stability data while potency methods mature.

Significance

ACTIMPs, including many peptide- and protein-based cancer vaccines, fall outside FDA's existing cell and gene therapy potency framework entirely, leaving developers of these products improvising an assay strategy without dedicated agency guidance; this draft closes that gap specifically and lands as part of CBER's broader 2026 guidance agenda alongside the CGT FAQ finalization above.

Redica Recommendation

Developers of peptide- , protein- , vectored- , or cell-based active immunotherapies should map their current potency-assurance strategy against the product-specific approaches here and submit comments before November 18, 2026, particularly on the personalized-neoantigen provisions if manufacturing relies on patient-specific bioinformatics pipelines.

‍Reference document: Potency Assessment of Active Immunotherapy Products - Draft Guidance for Industry - August 2026

8. Korea Proposes Simplifying Administrative-District Changes and Overhauling Investigational- Product GMP Requirements

Draft | Manufacturing Administration

MFDS's proposed amendment lets a pure administrative-district reorganization use a lighter change-report route. Comment period closes October 21, 2026.

Substance

The proposed amendment lets manufacturers, importers, and consignment manufacturing/sales operators whose registered manufacturing-site or business address changes solely due to an administrative district reorganization use a change-report procedure instead of the more burdensome existing authorization/report route, with similar simplification extended to clinical and nonclinical regulatory activities and a substantially accelerated clinical-trial application review timeline. Investigational medicinal product GMP requirements are extensively revised, touching investigational-drug orders, batch records, labeling-material samples, reference and retention samples, supplier verification, and facility qualification.

Significance

The proposal arrives inside MFDS's broader 2026 modernization push, which separately targets a 240-day approval timeline for biologics and biosimilars and expanded CDMO regulatory support, positioning this administrative and GMP overhaul as part of a coordinated effort to reduce compliance friction that doesn't reflect genuine safety risk while tightening the substantive investigational-product GMP expectations that do.

Redica Recommendation

Manufacturers and CROs operating investigational-product sites in Korea should review the revised GMP documentation requirements now, particularly batch-record and supplier-verification provisions, and flag any site currently mid-reorganization for the simplified change-report route once finalized.

Reference document: Legislative Notice of the Proposed Partial Amendment to the Regulation on Safety of Pharmaceuticals, Etc.

9. PMDA Consolidates Its MID-NET Application and Utilization Procedures

Final | Real-World Data

PMDA's consolidated MID-NET procedures cover the full request-to-closure lifecycle for Japan's post-marketing database network.

Substance

The consolidated procedures establish the detailed administrative steps and prescribed forms for requesting, obtaining approval for, and conducting a MID-NET utilization project, covering preliminary consultations, PMDA's application review and notification process, execution of the utilization agreement, and payment of the applicable user fee. The companion consolidated guideline defines MID-NET users, participating institutions, and analytical datasets, sets a standard two-year utilization period subject to specified extensions, and establishes review criteria including an eligible purpose, feasible study design, and use of the minimum necessary information.

Significance

MID-NET has operated as Japan's primary post-marketing real-world-data network since 2018, and this consolidation folds accumulated procedural refinements into current, citable text rather than leaving applicants to reconcile multiple standalone notices, at a point when Japan's broader real-world-evidence framework continues to expand alongside ICH M14's March 2026 adoption.

Redica Recommendation

Sponsors planning a MID-NET-based post-marketing safety or risk-benefit study should confirm their utilization request against the consolidated review criteria and two-year utilization-period rules before submitting a preliminary consultation request.

Reference documents: Handling of Administrative Processing Procedures for Applications, etc. Related to the Utilization of MID-NET, Guidelines on the Utilization of MID-NET

10. Japan Sets the Transitional Labeling Window for Peppermint Oil's OTC Reclassification

Final | OTC Reclassification

MHLW's amendment opens a one-year transitional labeling period tied to peppermint oil's Class 1-to-Class 2 OTC move. Applicability date August 31, 2026.

Substance

The amendment updates the binding ministerial designation table under Article 216-2(1) of the PMD Act Enforcement Regulation, deleting the existing peppermint-oil entry with an applicability date of August 31, 2025 and inserting a new entry dated August 31, 2026, which starts a fresh one-year transitional classification-labeling period. The change accompanies peppermint oil's reclassification from a Class 1 to a Class 2 OTC pharmaceutical, and a companion notification separately addresses handling of existing labeled product already in the supply chain.

Significance

Reclassifying an ingredient's OTC risk class changes the labeling and point-of-sale requirements that apply to it, and the one-year transitional window gives manufacturers and distributors a defined runway to exhaust existing Class 1-labeled stock rather than facing an abrupt cutover; this is a narrow but concrete compliance deadline for anyone holding peppermint-oil-containing OTC inventory.

Redica Recommendation

Manufacturers and distributors of peppermint-oil-containing OTC products in Japan should confirm existing Class 1 labeling is cleared from the supply chain within the one-year transitional window and update labeling artwork to Class 2 requirements.

Reference document: Partial Amendment to the Pharmaceuticals and Periods Designated by the Minister of Health, Labour and Welfare Pursuant to Article 216- 2, Paragraph 1 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

11. MHRA Refreshes Its ILAP and Scientific Advice Guidance, Tightening Advice-Request Documentation

Final | Innovation Pathways

MHRA's updated guidance requires complete briefing documents at the point of a scientific-advice request. New requirement effective September 2026.

Substance

MHRA's updated ILAP guidance describes the coordinated services available to Innovation Passport holders across clinical development, regulatory assessment, health-technology assessment, market access, and NHS adoption, including the core Target Development Profile service every holder receives and optional support recommended case by case. The companion scientific-advice guidance requires, from September 2026, that organisations submit their final questions and complete briefing documents at the time of the request rather than iterating afterward, and directs applicants to present a clear company position with rationale and scientific justification for each question.

Significance

Tightening the scientific-advice submission requirement shifts preparation burden earlier in the process, rewarding sponsors who arrive with a fully worked position over those who have historically used the advice meeting itself to develop their thinking; both updates continue MHRA's pattern of refining its innovation-support offerings incrementally rather than through a single consolidated overhaul.

Redica Recommendation

Sponsors planning to request MHRA scientific advice after September 2026 should prepare complete briefing documents and a defined company position for each question before submitting the request, rather than planning to develop that position during the meeting itself.

‍Reference document: What's on offer in the ILAP Medicines: get scientific advice from the MHRA

12. EMA Proposes Qualifying a Six-Registry Real-World Data Network for MS Safety Studies

‍Draft | Real-World Data

EMA's draft opinion would qualify the Big MS Data network's six registries as PASS data sources, with noted gaps in comorbidity and pregnancy data. Comments close September 18, 2026.

Substance

The draft qualification opinion proposes qualifying the Big Multiple Sclerosis Data Network and its six constituent registries as data sources for post-authorisation safety studies of MS disease-modifying therapies, while requiring a study-specific feasibility assessment for each individual registry rather than treating qualification as a blanket clearance. It finds generally strong coverage for demographics, disease characteristics, and treatment exposure, but identifies limitations for comorbidities, concomitant medicines, and pregnancy outcomes, and supports linking registries to national health databases, particularly the Danish and Swedish registries, where routine collection underreports safety outcomes.

Significance

A qualification opinion gives sponsors of MS disease-modifying therapies a pre-vetted real-world data source for regulatory-required safety studies, but the explicitly flagged gaps mean qualification narrows rather than eliminates the diligence needed before relying on any single registry, particularly for pregnancy-outcome or comorbidity-sensitive safety questions.

Redica Recommendation

Sponsors of MS disease-modifying therapies planning a PASS using Big MS Data network registries should run the required study-specific feasibility assessment early, with particular attention to pregnancy-outcome and comorbidity data gaps, and submit comments before September 18, 2026.

Reference document: Draft Qualification Opinion for the Big Multiple Sclerosis Data (BMSD) network

Appendix

Already a Redica subscriber? Log in to view all of the reference documents mentioned in this month's edition of the Redica Regulatory Review! Use this appendix to quickly find the one you're looking for with its associated RDR: 

Section 1

• Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

Section 2

• Determining Whether to Submit an ANDA or a 505(b)(2) Application - Draft Guidance for Industry - August 2026

Section 3

• Essential Principles and Content of Predetermined Change Control Plans

Section 4

• Key Points for Technical Review of Implantable Brain–Computer Interface Medical Devices for Motor Function Compensation (Draft for Public Comment)

Section 5

• Frequently Asked Questions - Developing Potential Cellular and Gene Therapy Products - Guidance for Industry - August 2026

Section 6

• Cell and Gene Therapy Drug Development Plan (Draft for Comments)
• "Pioneer Program" for Cell and Gene Therapy Drugs (Draft for Comments)

Section 7

• Potency Assessment of Active Immunotherapy Products - Draft Guidance for Industry - August 2026

Section 8

• Legislative Notice of the Proposed Partial Amendment to the Regulation on Safety of Pharmaceuticals, Etc.

Section 9

• Handling of Administrative Processing Procedures for Applications, etc. Related to the Utilization of MID-NET
• Guidelines on the Utilization of MID-NET

Section 10

• Partial Amendment to the Pharmaceuticals and Periods Designated by the Minister of Health, Labour and Welfare Pursuant to Article 216- 2, Paragraph 1 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Section 11

• What's on offer in the ILAP Medicines: get scientific advice from the MHRA

Section 12

• Draft Qualification Opinion for the Big Multiple Sclerosis Data (BMSD) network