Disclosure

FDA

EMA

HC

Pre-Marketing Application Disclosures

Filing of an Investigational New Drug Application (IND) (U.S.) / Request for Authorisation to Conduct a Clinical Trial (EU) / Clinical Trial Applications (Canada)

FDA does not disclose that an IND has been filed, accepted, or is currently open (unless already public). However, FDA does release the number of INDs filed quarterly.

Currently, a request for authorisation to conduct a clinical trial is reviewed by the Member State in which the trial will be conducted, and therefore EMA does not disclose information on these applications. After the Clinical Trials Regulation comes into application, information submitted in a request for authorisation to conduct a clinical trial will be publicly available in the EU Clinical Trial Database after approval or denial of the request unless the information is otherwise protected (e.g., commercially confidential).

While HC does not release information about requests (e.g., company, product, indication) it does publish the number of clinical trial applications received per year and the decisions made on those applications in its Therapeutic Products Directorate Drug Submission Performance Annual Reports.

Attainment of any designations or participation in programs and/or rationale for granting designation

FDA does not disclose the submission of a request for designations (orphan, breakthrough therapy, fast track, priority review, accelerated approval, regenerative advanced therapy designation, the qualified infectious disease product (QIDP) designation, and the limited population pathway for antibacterial and antifungal drugs), but does disclose drugs that receive an orphan designation and release the number of recipients of the other designations. Designation determinations may be available in summary review documents for approved products or disclosed in a public Advisory Committee meeting.

EMA releases information on designated orphan medicinal products, a fully list of orphan designated products, and a public summary of the COMP’s opinion. EMA discloses designation decisions for advanced therapy medicinal products (ATMPs; e.g., gene therapy, somatic cell therapy, tissue engineered product), and publishes a list of all PRIME products, updated monthly. EMA does not disclose the CHMP decisions on accelerated assessment until a final decision on the marketing authorisation application is made and then summary of CHMP’s assessment is released.

HC discloses whether a product is being review under priority review or NOC/c, the number of priority review status requests, and which new active substance approvals received priority review or NOC/c.

Marketing Application In-review Disclosures

Submission of a New Drug Application (NDA) or Biologics License Application (BLA) (U.S.) / Marketing Authorisation Application (MAA) (EU) / New Drug Submission (NDS) (Canada

FDA does not disclose the existence of an NDA or BLA (unless previously disclosed or acknowledged) unless and until approval of the product (or an Advisory Committee meeting occurs). FDA does release the number of NDA/BLAs submitted by month.

EMA publishes a list of new medicines under evaluation for a centralised marketing authorisation by EMA’s Committee for Medicinal Products for Human Use (CHMP) each month.

HC publishes a Submissions Under Review (SUR) List for New Drug Submissions (NDS). In addition, HC reports the number of new drug submissions received annually (by fee category).

Sponsor/agency meeting minutes or other correspondence throughout the review process

FDA does not provide any meeting minutes or other correspondence throughout the review process unless and until the product is approved, and then these materials may be included in the summary review documents posted publicly.

EMA does not provide any sponsor/agency meeting minutes or other correspondence throughout the review process, but these materials may be referenced in the EPAR after a decision on the marketing authorisation application has been made.

HC does not provide any sponsor/agency meeting minutes or other correspondence throughout the review process, but these materials may be referenced in the Summary Basis of Decision after a decision on the submission has been made.

Scientific/advisory committee meeting scheduling and materials

FDA’s website includes an Advisory Committee Calendar, which includes meeting rosters, final questions and agenda, meeting transcripts, and both FDA and industry briefing information.

EMA publishes the agendas and meeting minutes of its scientific committee meetings prior to approval of the marketing authorisation application for a product. For certain committees, EMA also releases highlights from meetings with “outcomes of major public interest”.

HC releases information on their scientific/expert advisory committee meetings and panel meetings on their website. This includes meeting announcements, agendas, and/or recordings of proceedings.

Status of marketing application during review

FDA does not disclose information on the status of NDAs/BLAs during review, including user fee goal dates /postponement of user fee goal dates and clinical holds/release of clinical holds.

EMA does not disclose the status of a marketing authorisation application until a decision has been made. EMA does not publish if a clinical trial is suspended as that is the decision of a Member State.

HC does not provide information about the status of a product in review.

Decision and Post-Decision Disclosures

Refuse-to-file letter (U.S.) / Validation Supplementary Information requests (EU) / Application deficiencies / Screening Deficiency Notice (Canada)

FDA does not disclose the existence or contents of a refuse-to-file letter.

EMA does not disclose the existence or contents of Validation Supplementary Information requests or negative validation letters.

HC does not disclose the existence or contents of Clarification Requests or Screening Deficiency Notices.

Positive Marketing Application Decisions: Action Package (U.S.) / European Public Assessment Reports (EU) / Summary Basis of Decision (Canada)

FDA provides a searchable database (Drugs@FDA) on all approved NDAs (and drug center reviewed BLAs). For new drugs, FDA publishes an action package with review documents outlining FDA’s determination (on Drugs@FDA).

After the EC final decision, EMA publishes EPARs (European Public Assessment Reports) online that outline EMA’s assessment of the marketing authorisation application as well as a lay summary of approval. Prior to the EC decision, EMA releases a Q&A document after the committee decision to recommend the MAA.

HC publishes Regulatory Decision Summaries (RDS) for new drug submissions and supplemental new drug submissions for new uses approved after April 1, 2015. For approvals issued on or after October 1, 2018, RDS are published for supplemental new drug submissions for new routes of administration, new dosage forms, and new strengths. A more detailed description of the basis for approval can be found in the Summary Basis of Decision (SBD).

Negative Marketing Application Decisions: Complete response letter (U.S.) / Refusal Public Assessment Report (EU) / Regulatory Decision Summaries (Canada)

FDA does not disclose the existence or contents of a complete response letter.

After a negative marketing authorisation application decision, EMA publishes a negative opinion Q&A document after the meeting and releases a Refusal Public Assessment Report on EMA’s website after an EC decision.

HC publishes Regulatory Decision Summaries (RDS) for final negative decisions for new drug submissions for new active substances accepted for review on or after April 1, 2015, and for new drug submissions and supplemental new drug submission for a new use accepted for review on or after May 1, 2016.

Withdrawn marketing applications

FDA does not release an action package for withdrawn applications.

EMA publishes the applicant’s withdrawal letter stating the reasons they withdrew the application. In addition, EMA publishes a Q&A document describing (in lay language) the scientific assessment of the product up to the time of the withdrawal. Additional documents that make up an EPAR are published within three months of the withdrawal letter.

HC publishes Regulatory Decision Summaries (RDS) for canceled submissions for new drug submissions for new active substances accepted for review on or after April 1, 2015, and for new drug submissions and supplemental new drug submission for a new use accepted for review on or after May 1, 2016.

Appeals of Marketing Application decisions

FDA does not disclose the existence or appeal decision unless and until the application is approved or a public advisory committee meeting is held.

EMA discloses the appeal decision as it would any other opinion (see above), with EMA updating the initial negative opinion Q&A document and other EPAR documents to reflect the reexamination outcome. In addition, if the reexamination is positive, EMA will publish a new positive opinion Q&A.

HC does not disclose the existence of a reconsideration or make the final decision (i.e., the reconsideration letter) public, but will revise the RDS and/or SBD, as needed.

Technical and lay clinical trials summaries

FDA does not release technical clinical trial summaries (clinical study reports or CSRs) or “lay summaries” for the broader public. In addition, while FDA lists the current PMRs/PMCs of products and their current status on its website, the Agency does not disclose the final summary reports of these clinical trials.

Clinical trial summaries submitted to EMA are available to the public through the EU Clinical Trials Register (EU CTR). When the new Clinical Trials Regulation comes into application, sponsors will be required to submit to the new EU Clinical Trial Portal clinical trial summaries, “layperson’s summaries”, and CSRs, which will all be available to the public. EMA also publishes clinical reports submitted to the Agency for approved, rejected and withdrawn applications.

In March 2019, new HC regulations came into force that allow public release of certain clinical trial information, including clinical overviews, clinical summaries, and clinical study reports after a drug receives a final decision on its marketing application. HC does not require or release lay summaries.

Agency-created analysis of data

FDA does not release Agency created data analyses, but after FDA approves an NDA or BLA, any Agency-created data analyses may be disclosed in the action package and/or prior to approval disclosed as part of FDA’s briefing package for an Advisory Committee meeting.

EMA does not release Agency created data analyses unless they are referenced and/or included in the published EPAR.

HC does not release Agency created data analyses unless they are referenced and/or included in the published RDS and/or SBD.

Pharmacovigilance / Risk Evaluation and Mitigation Strategy (REMS) (U.S.) / Risk Management Plan (RMP) (EU) / Risk Management Plan (RMP) (Canada)

FDA publishes information on adverse event reports through a searchable public dashboard. FDA also issues safety alerts for recalls and risks of adverse reactions, and potential signals of serious risks/new safety information identified. After an NDA or BLA is approved, FDA publishes any approved Risk Evaluation and Mitigation Strategy (REMS) for that product on FDA’s website.

EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports. EMA publishes information about single assessments of related PSURs (PSUSAs) and updates EPARs as necessary. In addition, EMA publishes a list of medicines assessed in a PSUSA. EMA also publishes information about assessments of the results of post authorisation safety studies (PASSs), updates EPARs as necessary, and publishes a list of medicines assessed. A list of all medical products currently being followed under additional monitoring can be found on EMA’s website, as well as summaries of risk management plans. Information about safety (and other types of) referrals is available online. In addition, meeting highlights disclose the start of a safety referral and a committee’s recommendation or decision.

The Canada Vigilance online database contains publicly searchable information about suspected adverse reactions to health products. In addition, advisories and recalls can be found in the Recalls and Safety Alerts Database. HC does not publish risk management plans.

Patient-level clinical trial data

FDA does not disclose any patient-level clinical trial data.

Currently, EMA does not disclose any patient-level clinical trial data. However, this will change when Phase 2 of EMA’s policy on the publication of clinical data (Policy 0070) comes into application. When it does, individual patient data (IPD) from a clinical trial will be publicly available for download and use for academic and non-commercial research purposes.

HC does not release individual patient records.

Agency pooled data sets

FDA does not release any Agency-pooled data sets.

EMA does not release any Agency-pooled data sets.

HC does not release any Agency-pooled data sets.

Supplemental application (U.S.) / Extension to Indication or Variation (EU)/ Supplemental application

FDA does not disclose the existence of a supplemental NDA or BLA (unless previously disclosed or acknowledged) unless and until approval of the product (or an Advisory Committee meeting occurs). FDA does release the number of supplemental applications submitted by month.

Unlike for a new MAA, EMA does not publish a list of pending extension to indication or variation applications.

HC publishes a Submissions Under Review (SUR) List that includes supplemental new drug submissions for new uses accepted for review on or after May 1, 2016 that are currently or formerly under review. In addition, HC releases the number of supplemental new drug submissions received annually (by fee category).