Medicines and Healthcare products Regulatory Agency (MHRA)
Updates on MHRA Regulatory Flexibilities resulting from Coronavirus (COVID-19) guidelines
The MHRA issued additional updates to the guidelines in July 2020. Information for manufacturers of human plasma-derived medicines during the coronavirus (COVID-19) outbreak was added to the guidelines. The MHRA is offering to provide temporary inspection flexibility in exceptional circumstances. The MHRA describes which control measures will be implemented depending on whether third country plasma collection sites have been previously inspected by the MHRA or not. For example, in the case of third country plasma collection sites that have been previously inspected by the MHRA, a control measure will be implemented in line with EMA recommendation EMA/INS/GMP/534269/2018 “Application of inspection and control measures”. A Statement of Next Inspection (SONI) will be issued, stating the recommended date of the next inspection. For more details please follow a link below.
New Publications by the MHRA Inspectorate Blog
The MHRA announced on 23rd July 2020 that the Agency is planning to return to on-site Good Practice (GxP) inspections. The post states that during the past few weeks the MHRA has been engaging with industry trade associations and the United Kingdom National Health Service to discuss the practical arrangements that may be required to facilitate on-site inspection starting in September and scaling up to a full programme from October 2020. Inspection conduct will vary according to the requirements of each GxP area and may include a hybrid model of on- and off-site activities that support a single inspection cycle. Further information is planned to be available later in the summer.
Until the full programme resumes, the MHRA will continue to conduct its current COVID-19 programme of remote assessment. Consistent with previous guidance, on-site inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk, and where remote assessment is not possible, will continue until September as normal programmes resume. There are currently no plans for a return to international inspections, where the MHRA continue to rely on remote assessment procedures and communication with the international regulatory network.
On 15th July 2020 Terry Madigan published the article on Quality Risk Management (QRM) in Good Distribution Practice (GDP). The QRM is a requirement of GDP. Terry gives a reminder on the definition of the QRM, which is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle and refers to EU GDP Guidelines SI 2013/C343/01. A practice example of an assessment of transport chains is provided in the article to illustrate the principles of the QRM. The author goes through risk assessment, risk control, risk communication, and risk review and summarises common weaknesses as well as good practices seen with GDP quality risk management.
On 30th June 2020 the MHRA issued a post to outline the MHRA and the Food and Drug Administration (FDA) collaboration on the topic of data integrity. A joint paper ‘Data Integrity in Global Clinical Trials’ was published on 20th January 2020. The author of the MHRA post, Gail Francis, states that ‘The paper talks about the need for robust processes to manage data, throughout its Lifecyle, using a risk-based approach. Data integrity also relies on organisations having an open culture with regards to reporting any issues, with proportionate management of those failures. The paper then goes on to discuss some specific areas where Regulators have seen issues that impact on data integrity, such as audit trails, maintaining the study blind and general data management practices. Each section includes case studies where the MHRA and FDA have raised concerns during GCP inspections.
European Medicines Agency (EMA)
COVID-19: EMA sets up Infrastructure for Real-World Monitoring of Treatments and Vaccines
The EMA has set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. The EMA has signed three contracts for observational research with academic and private partners over recent months, to be ready to effectively monitor vaccines in the real world as soon as they are authorised, and support the safe and effective use of COVID-19 vaccines and medicines.
In July the contract was finalised with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’). This project will collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women.
In June, EMA contracted the company IQVIA with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients. The project will be carried out in collaboration with the European Health Data & Evidence Network (EHDEN) consortium, which was established under the Innovative Medicines Initiative and includes the Erasmus Medical Centre in Rotterdam and the University of Oxford as project lead and research coordinator, respectively.
In May 2020, the EMA commissioned the ACCESS project (‘vACcine Covid-19 monitoring readinESS’) for preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice, once authorised.
The EMA is also contributing to COVID-19 work to strengthen methods guidance, transparency and international collaboration.
Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials Guidelines were revised
The guidance was revised by the EMA on 29 June 2020 following a four-week public consultation.
Update added to Guidance for Medicine Developers and Companies on COVID-19:
EMA provided a template and dedicated email address for notifications of exceptional change management process (ECMP), as foreseen in the questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.
Public Consultation on EMA and Heads of Medicines Agencies (HMA) Joint Network Strategy to 2025 was launched
The strategy for the next five years developed by the EMA and the HMA was released for a two-month public consultation on 6th July 2020 which details how the European Medicines Agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic. The draft strategy outlines the following priority areas for the network:
- the availability and accessibility of medicines;
- data analytics, digital tools and digital transformation;
- antimicrobial resistance and other emerging health threats;
- supply chain challenges; and
- the sustainability of the network and operational excellence.
Input on the draft strategy document is welcome from all stakeholders, including members of the public, until 4th September 2020. The strategy will be considered for adoption by the HMA and EMA Management Board towards the end of 2020.
EMA Update on Treatments and Vaccines for COVID-19
Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying) given by infusion (drip) into a vein has been authorised for marketing authorisation in the European Union under the invented name Veklury, since 3rd July 2020. It has a conditional marketing authorisation for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.
The EMA has been in discussion with the developers of 36 potential COVID-19 vaccines and 148 potential COVID-19 treatments (these include immunomodulators, antivirals and hyperimmune serums); also the EMA has finalised nine scientific advice procedures to provide developers with direction on the most appropriate methods and study designs for potential COVID-19 medicines. A further 13 such procedures are ongoing (figures correct as of 15th July 2020).
During the COVID-19 pandemic, the EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.
For more details about Remdesivir, potential treatments and vaccines under investigation, exceptional transparency measures, real-world monitoring of COVID-19 treatments and vaccines, information on ongoing observational studies in the EU, and information on ongoing clinical trials in the EU please follow the link below.
International Regulators align Positions on Phase 3 COVID-19 Vaccine Trials
On 9th July 2020 medicines regulatory authorities from around the world have published a report highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
The report describes the regulatory positions agreed by the meeting participants on two key topics:
- Data needed from laboratory, animal and human studies to allow initiation of phase 3 clinical trials for a COVID-19 vaccine; and
- Considerations for study design for phase 3 clinical trials.
For the latest updates on the COVID-19 pandemic from the EMA, including all news and press releases, please follow the link below:
Food And Drug Administration
New updates on FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
Since the last update released on 3rd June 2020, the FDA issued further updates on the guidance on 2nd July 2020. The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation. In addition, the guidance includes a new question-and-answer regarding how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits.
The FDA published Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing guidance
On 19th June 2020 the FDA published “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing” guidance, that provides recommendations to pharmaceutical manufacturers, including outsourcing facilities, concerning current good manufacturing practice (CGMP) requirements and expectations to prevent contamination of drugs and exclude sick workers from directly engaging in drug manufacturing. The guidance provides additional recommendations regarding maintaining the drug supply during the COVID-19 public health emergency.
The FDA has issued a draft guidance on Development of Anti-Infective Drug Products for the Pediatric Population for comments
The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for the pediatric population. Comments on the guidelines are expected by 29th August 2020.
Draft Guidance to Encourage Cannabis-Related Clinical Research by FDA
On 21st July 2020 the FDA has issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry”, which describes the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds and covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels. Comments on the guidelines are expected by 21st September 2020.
Issue Number: RN2007
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