I am writing to request information under the Freedom of Information Act 2000. This request relates to MHRA's institutional capacity, performance, and strategic planning regarding the assessment of Advanced Therapy Medicinal Products and the UK's position as a regulatory jurisdiction. It does not seek information about any specific marketing authorisation application. 1. ATMP assessment capacity and resourcing Please provide: (a) The number of MHRA staff (full-time equivalent) currently assigned to or qualified to assess marketing authorisation applications for Advanced Therapy Medicinal Products. (b) Any internal assessments, reports, or board papers produced since January 2023 regarding MHRA's capacity to assess ATMP applications within statutory timeframes. (c) Any internal assessments or reports identifying ATMP assessment capacity as a risk, constraint, or area requiring additional resourcing. (d) Whether MHRA has recruited or sought to recruit additional ATMP assessment expertise since January 2023, and if so, the number of positions and whether they have been filled. 2. Regulatory competitiveness and industry feedback Please provide: (a) Any internal assessments, board papers, or ministerial correspondence produced since January 2023 regarding the UK's attractiveness as a regulatory jurisdiction for ATMP developers, including any analysis of whether MHRA assessment timelines are competitive with the EMA and FDA. (b) Any correspondence between MHRA and the Department of Health and Social Care regarding ATMP assessment backlogs, delays, or capacity constraints since January 2023. (c) Any feedback, complaints, or representations received from pharmaceutical or biotechnology companies regarding MAA assessment timelines under the national procedure since January 2023. I request this in aggregate or anonymised form if individual company identities are commercially sensitive. (d) Any analysis conducted by MHRA comparing its MAA assessment timelines (including clock-stop periods) with those of the EMA, FDA, or other comparable regulators. 3. MAA backlog and performance reporting Please provide: (a) MHRA's published and internal MAA backlog figures for each quarter from Q1 2023 to present, including the number of applications awaiting assessment, in active assessment, in clock-stop, and awaiting decision. (b) Any internal performance reports or KPI dashboards relating to MAA assessment timelines, including whether statutory targets were met, for 2023, 2024, and 2025. (c) Any correspondence or reports prepared for the MHRA Board, the Commission on Human Medicines, or ministers regarding MAA assessment performance or backlogs since January 2023. 4. Impact of regulatory delays on patient access Please provide: (a) Any internal assessments or reports regarding the impact of MAA assessment delays on patient access to medicines in the UK, particularly for treatments addressing serious or life-threatening conditions with high unmet medical need. (b) Any internal assessments regarding whether MHRA's MAA assessment timelines for oncology or ATMP products are consistent with the Agency's stated commitment under the Innovative Licensing and Access Pathway (ILAP) to accelerate patient access to innovative treatments. (c) Any correspondence with NICE regarding the impact of MAA assessment timelines on NICE's ability to conduct timely technology appraisals for products in the MHRA assessment pipeline. 5. Parliamentary and public accountability Please provide: (a) Any briefing materials prepared by MHRA for parliamentary questions, select committee inquiries, or ministerial briefings regarding MAA assessment timelines or ATMP assessment capacity since January 2023. (b) Any responses prepared by MHRA to Freedom of Information requests regarding MAA assessment timelines or backlogs since January 2023. I request these in anonymised form if applicant identities are subject to exemption.
Published: 23 March 2026
I am writing to request information under the Freedom of Information Act 2000. This request does not seek information about any specific marketing authorisation application. It relates solely to MHRA's general policies, procedures, and aggregate performance data regarding the assessment of marketing authorisation applications. 1. Clock-stop policies and limits Please provide: (a) MHRA's written policies or guidance governing the use of clock-stops during the assessment of marketing authorisation applications under the national procedure, including any policies specific to Advanced Therapy Medicinal Products (ATMPs). (b) Whether MHRA imposes any maximum permissible duration for a single clock-stop period, or any cumulative maximum for total clock-stop time during an MAA assessment. If so, please provide the applicable limits. (c) Whether MHRA has any policy or mechanism for escalating, intervening in, or expediting an MAA assessment where clock-stop periods become prolonged. If so, please provide the relevant policy or procedural document. (d) Whether MHRA has any obligation to notify the public, patients, patient advocacy groups, or healthcare professionals when an MAA assessment for a serious or life-threatening condition exceeds published statutory timeframes due to extended clock-stops. 2. Aggregate MAA processing statistics Please provide: (a) The total number of marketing authorisation applications currently under assessment via the national procedure (not reliance or cooperative procedures), broken down by product category (small molecule, biologic, ATMP, other). (b) The average total assessment time (clock-on time only, excluding clock-stops) for national procedure MAAs completed in 2024 and 2025, broken down by product category. (c) The average total clock-stop time for national procedure MAAs completed in 2024 and 2025, broken down by product category. (d) The number of national procedure MAAs currently in active clock-stop, and of those, how many have been in clock-stop for more than 6 months and more than 12 months. 3. CHM meeting procedures for MAAs Please provide: (a) MHRA's published or internal guidance on the number of CHM meetings typically required before a marketing authorisation decision is reached under the national procedure. (b) Whether there is any published or internal guidance on the expected timeframe between a final CHM meeting and the issuance of a marketing authorisation decision. (c) The number of national procedure MAAs assessed in 2023, 2024, and 2025 that required more than two CHM meetings before a decision was reached. 4. Label expansion during active MAA assessment Please provide: (a) MHRA's policy or procedural guidance on whether an applicant may seek to expand or modify the proposed indication of a product during an active MAA assessment, as distinct from a post-authorisation variation. (b) If such a procedure exists, whether it has been used for any national procedure MAA in the last three years, and the number of instances. (c) If no such procedure exists, confirmation that no formal pathway exists for mid-assessment label expansion. 5. External control trial (ECT) guidance Please provide: (a) The current status of MHRA's guidance on the acceptability of external control arms and real-world evidence in marketing authorisation applications, including any expected publication date. (b) Any draft or consultation versions of this guidance that have been circulated to stakeholders. If any part of this request exceeds cost or scope limits under Section 12, I would appreciate advice on how the request may be refined to remain within statutory limits.
Published: 23 March 2026
I am writing to request access to information under the Freedom of Information Act 2000 regarding the evidence base for psychiatric diagnoses and pharmacological treatment as classified in: * ICD-10, Chapter F00-F99 (Mental and Behavioural Disorders) * ICD-11, Chapter 06 (Mental, Behavioural or Neurodevelopmental Disorders) * DSM-5 (where applicable) To avoid unnecessary document production and ensure clarity, I am requesting only clear YES/NO answers to the questions below, along with - where relevant - document titles, dates, and document types. I am not requesting document delivery at this time. A. EVIDENCE BASE (Causation and Causal Treatment) 1. Measurable Biological Cause Does MHRA possess documentation of measurable biological causes (e.g., biomarkers, laboratory measurements, neurochemical indicators, or imaging diagnostics) that can diagnose one or more psychiatric disorders in ICD-10/ICD-11/DSM-5 on a biological basis? Answer: YES / NO If YES, please provide: Document title, date, and type 2. Causal Treatment Does MHRA possess documentation that pharmacological treatment used for psychiatric disorders corrects or normalizes a demonstrated biological cause of these disorders? Answer: YES / NO If YES, please provide: Document title, date, and type 3. Clinical Threshold Values Does MHRA possess documents with clinical normal or threshold values for biological parameters (e.g., neurotransmitters, hormones, or other measurable substances) that are used to define disease thresholds for psychiatric diagnoses in ICD-10/ICD-11/DSM-5? Answer: YES / NO If YES, please provide: Document title, date, and type 3B. Prescription Thresholds for SSRI/Psychiatric Medication Does MHRA possess documentation establishing minimum and/or maximum threshold levels (biological markers, severity scores, or measurable parameters) that determine when SSRI or other psychiatric medication should be: * Initiated (minimum threshold for prescription) * Discontinued (maximum/recovery threshold) * Adjusted in dosage Answer: YES / NO If YES, please provide: Document title, date, and type Supplementary question: If no measurable thresholds exist, does MHRA possess documentation explaining the clinical decision-making criteria used to determine when medication is indicated versus when it should be discontinued? Answer: YES / NO If YES, please provide: Document title, date, and type 4. Correction Documented by Measurements Does MHRA possess documentation that psychiatric medication corrects a demonstrated biological abnormality, documented by measurements before and after treatment, for diagnoses covered by ICD-10/ICD-11/DSM-5? Answer: YES / NO If YES, please provide: Document title, date, and type 5. Children's and Adolescents' Neurobiology Does MHRA possess documentation of what psychiatric medication does to a normal, developing brain in children and adolescents, including any long-term neurobiological consequences, in relation to psychiatric diagnoses in ICD-10/ICD-11/DSM-5? Answer: YES / NO If YES, please provide: Document title, date, and type 5B. Rationale for Not Testing Before Prescribing Does MHRA possess documentation or scientific rationale explaining why serotonin levels (or other relevant neurotransmitter levels) are not measured or tested before prescribing SSRI, SNRI, or other psychiatric medications that are purported to affect neurotransmitter function? Answer: YES / NO If YES, please provide: Document title, date, and type Supplementary question: If such testing is deemed unnecessary, does MHRA possess documentation explaining how treatment can be considered causal or corrective without baseline measurements? Answer: YES / NO If YES, please provide: Document title, date, and type 5C. Treatment Duration and "Cure" Criteria Does MHRA possess documentation establishing: * The expected duration of psychiatric medication treatment required to "cure" or resolve the underlying biological abnormality * Criteria for determining when the biological cause has been successfully corrected and medication can be safely discontinued * Evidence-based protocols for distinguishing between "treatment completion" and "lifelong treatment requirement" Answer: YES / NO If YES, please provide: Document title, date, and type 5D. Dependency, Tolerance, and Withdrawal Does MHRA possess documentation addressing: * Whether psychiatric medications (particularly SSRI/SNRI) create physical dependency or neuroadaptation * Documented withdrawal syndrome profiles and their distinction from "relapse" or "return of original symptoms" * Guidelines for differentiating between: (a) withdrawal symptoms, (b) rebound effects, and (c) return of underlying condition * Expected timelines for neurobiological normalization after medication cessation Answer: YES / NO If YES, please provide: Document title, date, and type 5E. Diagnostic Stability and Medication Effect Does MHRA possess documentation examining: * Whether psychiatric diagnoses remain stable or change when patients are medication-free versus medicated * Studies tracking whether the same patients receive different diagnoses when assessed off-medication versus on-medication * Evidence for whether psychiatric medications affect the diagnostic process itself (i.e., whether medicated brain states create different symptom profiles that lead to different diagnoses) Answer: YES / NO If YES, please provide: Document title, date, and type 5F. Comparative Efficacy: Medication vs. Natural Recovery Does MHRA possess documentation comparing: * Long-term outcomes (5+ years) for medicated patients versus unmedicated patients with the same initial diagnoses * Natural recovery rates without pharmaceutical intervention * Studies examining whether early medication intervention improves, worsens, or has no effect on long-term outcomes compared to delayed intervention or no medication Answer: YES / NO If YES, please provide: Document title, date, and type 5G. Mechanism of Action Verification Does MHRA possess documentation demonstrating: * The actual mechanism by which SSRI/SNRI medications produce clinical benefits (if the serotonin deficiency hypothesis is not supported) * Alternative explanatory models for how these medications work if not through correcting a measurable biological deficiency * Evidence distinguishing between "mechanism of drug action" (how the drug affects the brain) and "mechanism of therapeutic effect" (why that action produces symptom reduction) Answer: YES / NO If YES, please provide: Document title, date, and type 5H. Placebo-Controlled Long-Term Studies Does MHRA possess documentation of: * Placebo-controlled studies extending beyond 12 weeks for psychiatric medications * Long-term (1+ year) randomized controlled trials comparing medication to placebo * Studies examining whether initial placebo-medication differences persist, diminish, or reverse over extended treatment periods Answer: YES / NO If YES, please provide: Document title, date, and type 5I. Informed Consent and Biological Uncertainty Does MHRA possess documentation or guidelines addressing: * How clinicians should inform patients about the absence of biological testing before psychiatric medication prescription * Required disclosures about the unproven nature of the biological basis for psychiatric diagnoses * Standards for informed consent when prescribing medications that alter brain chemistry without prior measurement of brain chemistry * Guidance on explaining to patients that psychiatric medications are prescribed based on symptom reports rather than biological measurements Answer: YES / NO If YES, please provide: Document title, date, and type 5J. Polypharmacy and Drug Interactions Does MHRA possess documentation regarding: * Evidence base for combining multiple psychiatric medications (e.g., SSRI + antipsychotic + mood stabilizer) * Studies demonstrating that combined psychiatric medications are more effective than monotherapy for specific measurable biological abnormalities * Guidelines for determining which biological markers indicate need for polypharmacy versus monotherapy * Long-term neurobiological effects of psychiatric polypharmacy, particularly in developing brains Answer: YES / NO If YES, please provide: Document title, date, and type 5K. "Treatment-Resistant" Patients Does MHRA possess documentation explaining: * Why some patients are labeled "treatment-resistant" if the medication is supposed to correct a biological deficiency (i.e., why would correcting a deficiency fail in some patients?) * Whether "treatment resistance" indicates the absence of the purported biological abnormality in those patients * Biological markers that distinguish "treatment-resistant" from "treatment-responsive" patients before treatment begins * Whether "treatment resistance" might indicate that the underlying causal model is incorrect Answer: YES / NO If YES, please provide: Document title, date, and type B. TREATMENT PROTOCOLS AND TREATMENT STANDARDS 6. Diagnosis-Specific Treatment Protocols Does MHRA possess standardized treatment protocols, treatment pathways, algorithms, flowcharts, or instructions linked to specific ICD-10 and/or ICD-11 diagnoses? Answer: YES / NO If YES, please provide: Document title, date, and type 7. Pharmacological Treatment Protocols Does MHRA possess documents describing initiation, dosing, dose adjustment, monitoring, treatment duration, and discontinuation of psychiatric medication per diagnosis? Answer: YES / NO If YES, please provide: Document title, date, and type 8. Age-Differentiated Protocols Does MHRA possess separate treatment protocols or instructions for children, adolescents, and adults? Answer: YES / NO If YES, please provide: Document title, date, and type 9. Combination Treatment Does MHRA possess protocols or standards for combining pharmacological and psychological treatment? Answer: YES / NO If YES, please provide: Document title, date, and type 10. Treatment Follow-up and Effect Monitoring Does MHRA possess documents describing how treatment effect, side effects, deterioration, and dropout are monitored and documented? Answer: YES / NO If YES, please provide: Document title, date, and type 11. Update and Revision Basis Does MHRA possess documents specifying when and on what professional basis existing treatment protocols are revised? Answer: YES / NO If YES, please provide: Document title, date, and type REQUEST SPECIFICATION I am requesting only a clear confirmation of whether the above documentation exists or does not exist in MHRA's possession, in accordance with Freedom of Information Act 2000. If documentation does not exist, I request an explicit confirmation of this fact. I prefer to receive the response in electronic format. BACKGROUND AND PURPOSE This request is part of research into the evidence base for psychiatric treatment recommendations across different national health authorities. The purpose is to understand what documented biological evidence exists for psychiatric diagnoses and whether current pharmacological treatments have documented causal mechanisms.
Published: 23 March 2026
