August 2023

Medicines and Vaccines

ICH

The slide deck prepared by the Innovation Office & Clinical Trials Branch of the Health Products Regulation Group for the Public Webinar held on 1 Aug 2023 on the draft ICH E6 (R3) Good Clinical Practice (GCP) Guideline has been published on the HSA website.

CTR and CTIS

  1. The next Clinical Trials Information System (CTIS) Walk-in clinic is scheduled for 20 September 2023. No registration is required to follow  the live broadcast on the EMA’s website.
  2. The latest issue of the Clinical Trial Highlights newsletter is available and is the first issue to be created in Newsroom. Subscribe to receive future issues.

  3. The EMA has developed a CTIS Sponsor User Training Programme to support sponsor user preparedness with regard to the new way of submitting Clinical Trial Applications in the EEA via CTIS. You can register for the September course at the following link.

FDA Guidance and News

  1. FDA and CTTI will host a free two-day virtual public workshop to discuss existing public health emergency (PHE) recommendations and to discuss advanced planning approaches to mitigate the disruption of clinical studies during disasters and PHEs.. See the ‘Development Strategy News’ subsection below for details.

  2. FDA has released draft guidance on postapproval trial diversity data. The guidance outlines several post marketing strategies that can be used to increase the safety and efficacy data on populations that were under-represented in initial clinical trials of drugs and biologics. The draft guidance entitled: “Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products: Guidance for Industry” is open for consultation until 10 October 2023. The draft guidance includes sections describing “..design and statistical considerations for various postmarketing approaches to provide additional information regarding traditionally under-represented populations…”.

  3. FDA has issued the final guidance Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors. This guidance is intended to assist IRBs, clinical investigators and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. For more information, please see the announcement. 

  4. In a 3-part webinar series, FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements. Learn more here. 

  5. FDA, together with the Clinical Trials Transformation Initiative (CTTI), is holding a virtual public workshop “to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups”. The free two-day virtual workshop will be held on 29 and 30 November 2023 from 10 a.m. – 2 p.m. EST. Registration for the workshop is now open and the workshop  agenda can be viewed here.

  6. FDA has issued a final guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. The guidance discusses the applicability of FDA's investigational new drug application regulations under 21 CFR part 312 to clinical study designs that use real-world data (RWD) and clarifies the agency's expectations for sponsors submitting new drug applications or biologics license applications using RWD to support the safety or effectiveness of a drug in clinical studies that are not subject to 21 CFR part 312.

EMA Guidance and News

  1. The EMA has updated “Clinical Data Publication (CDP) Questions and Answers (Q&As) on the External Guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070)” (26 July 2023; EMA/14227/2017, Rev. 3).  The updates include 10 new questions, two clarify that interim study reports and clinical results from ongoing blinded studies are to be published. Updates to the anonymisation report related questions are also presented together with a question regarding publication of the same Clinical Study Report under Policy 0070 and Clinical Trial Regulation which confirms EMA expects “the same level of CCI redaction applied in the CSR published on Clinical Data Publication portal (under Policy 0070 initiative) should be applied in the CSR provided in CTIS”.

  2. On 06 June 2023, EMA published an update of the 2015 tabular format paediatric consent guidance. The 12-page document was prepared by the European Network of Paediatric Research at the EMA. 

  3. On 18 August 2023, EMA released minutes from the Clinical Trial Advisory Group meeting held in June 2023 which discussed the implementation of the CTR along with transition trials.
  4. EMA has released Meeting Reports from the multi-stakeholder workshop on ICH E6(R3) - Public Consultation - held in July. The aim of the workshop was to engage all stakeholders of ICH E6(R3), including but not limited to, patient, healthcare professionals, assessors, inspectors, industry and academia.

Development Strategy News

  1. FDA and CTTI will host a free two-day virtual public workshop to enhance clinical study diversity on 29 and 30 November 2023 10 a.m. – 2 p.m. ET. Agenda here. Register here. The workshop will solicit input on increasing the enrolment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.

Representatives from drug sponsors, medical device sponsors, clinical research organisations, academia, patients, and other stakeholders will share their experiences and approaches for increasing enrolment and encouraging participation of historically underrepresented populations in clinical studies.

  1. FDA’s CDER and CTTI are hosting a two-day virtual public meeting on 18 and 19 October 2023 from 10.00 to 13.30 ET on both days and this is free to attend. The topic is ‘Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies’. During the COVID-19 public health emergency (PHE), FDA provided recommendations to mitigate the disruption of clinical studies. Join the meeting to discuss these recommendations and to discuss advanced planning approaches to mitigate the disruption of clinical studies during disasters and PHEs. Meeting agenda here; register here.

  2. This CenterWatch article shows that the FDA’s draft guidance on conducting decentralized trials (DCT) needs more detail on oversight of and responsibility for providers of remote services, according to comments from industry groups and sponsors. Access all the comments here.

  3. On 30 November 2023, the annual Synthetic Data Summit will take place in London, UK. This year’s summit will bring the latest developments and experiences together to provide a comprehensive perspective on what synthetic data generation is and what technologies have been found to work in practice, how it has been applied to solve healthcare challenges, how it is and should be regulated, and what the future holds / expected developments moving forward. Khaled El Emam from Replica Analytics will be presenting “Ten things I have learned about synthetic data generation.”

News from Asia Regulators

  1. In June 2023, China NMPA introduced a pilot program to adjust the font and format of drug package inserts to make them more elderly friendly. The program only applies to drugs that are indicated for the elderly population. For the program, the NMPA released a draft guidance for developing simplified package inserts and a draft specifications of the format of electronic package inserts. (Page in Mandarin)

  2. In July 2023, China NMPA released a revised list of medical devices exempted from clinical evaluation with immediate effect. The list now contains 1025 Class II/III medical devices. (Page in Mandarin)

Artificial Intelligence/Machine Learning

The deadline for the second submission cycle of the FDA’s Advancing Real-World Evidence (RWE) Program is September 30, 2023. FDA has also updated the Advancing RWE Program website to include a section addressing frequently asked questions the agency received during the Advancing RWE Program’s first submission cycle, ending on March 31, 2023. For more information on the program, visit the Advancing Real-World Evidence Program webpage.

Medical Devices

Medical devices information is kindly compiled by Raquel Billiones.

Updates from the European Commission

Regulation (EU) 2023/607 15 March 2023 amended the EU MDR and EU IVDR with regard to the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The new regulation allows certain legacy devices (depending on class) to remain in the market until 2027/2028.

Updates from the US FDA

  1. The FDA Center for Devices and Radiological Health has a Guidance for the Qualification of Medical Device Development Tools (MDDT). This guidance describes the framework for voluntary proposal and qualification of an MDDT.
  2. The FDA partnered with ECRI (originally founded as Emergency Care Research Institute), an independent non-profit organisation, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation, which is published as Medical Device Material Safety Summaries.

Updates from Switzerland

The swissdamed is the Swiss Database on Medical Devices. It was launched by Swissmedic to apply the Swiss regulations on medical devices and in vitro diagnostic medical devices. After the pilot phase in June 2023, Swissmedic issued the following updates on the swissdamed schedule:

  1. Registration of companies and economic operators – ACT module (available early 2024)
  2. swissdamed – freely accessible platform (available early 2024)
  3. Registration of devices – UDI module (available from summer 2024)

Updates from Australia

  1. TGA Australia has issued a guidance document on the requirements for active medical devices. Active medical devices are a subset of devices that use energy to operate.
  2. TGA Australia also issued a guidance document on the Transition to New Manufacturer Evidence for IVD Medical Devices. The guidance provides details on new manufacturer evidence requirements.

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