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Apr 7, 2020

Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak
On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.

MHRA is aware of the challenges arising from COVID-19 and will maintain a flexible and pragmatic approach to the regulatory requirements for the ongoing clinical investigations. Any new submissions for clinical investigations that will have a direct impact on the COVID-19 emergency will get a fast-track review.

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EMA EudraVigilance Registration Manual
On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.

The EudraVigilance XCOMP (Test system) has been aligned with Production. For more detailed information on the EV XCOMP registration process, please refer to Section 7 of this manual.

To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed:

1. A person within the organisation needs to be chosen as being responsible for managing the organisation and its users in the EudraVigilance Production system. If the organisation is a marketing authorisation holder the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV).

2. Register for an EMA user account in the EMA Account Management portal if you do not already have one - see 2. User registration with EMA Account Management portal (IAM)

3. Check Organisation Management System (OMS): if your organisation is not present in OMS it will need to be registered -see 4. Create a new Organisation

4. Submit request to be registered as the responsible person for the organisation -see 3.2. EU QPPV or Responsible Person access request

5. Complete organisation registration details in the EudraVigilance restricted area - see 4.1. Finalise organisation information in EV Human Production and XCOMP

6. Set up the transmission mode - see 5.1. EV restricted area and transmission mode for new organisation

7. Raise Service Desk ticket to set up Gateway connection or a Webtrader connection if you need to send XEVMPD messages

8. Once the QPPV or responsible person is registered for the Production EudraVigilance system they will automatically also be registered for an XCOMP test account for the same organisation.

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Global Regulators Map out Data Requirements for Phase 1 COVID-19 Vaccine Trials
On 24 March 2020 the EMA announced that global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development.

Global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points:

  • Pre-clinical data required to support proceeding to first-in-human clinical trials with investigational medicinal products;
  • The need to address the known theoretical risk that vaccines against COVID-19 enhance the disease prior to starting first-in-human clinical trials.

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EMA Management Board – highlights of March 2020 meeting
On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.

The Management Board endorsed the CTIS audit methodology enabling the process for the selection of the supplier for the audit of the system to commence. The audit is planned to begin in December 2020.

Further to the endorsement in December 2019 of the ‘audit readiness assessment’ the Board noted that a second assessment is being carried out in the first months of 2020 to further identify critical items that must be addressed prior to the audit. So far, the Union Control and Inspection modules of CTIS have been assessed by specialised users in those areas, in collaboration with the product owners. This assessment will be completed in April 2020 and will be followed by a further operational assessment including of the public portal to allow determining the full scope of the auditable version of the system.

The Board also noted the progress in the development of CTIS by the supplier, with reassurance being provided by the results of the last sprints. The supplier performance and quality will continue to be closely monitored to ensure timely delivery of a reliable audit version of CTIS.

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EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
On 20 March 2020 the EMA issued this guidance for industry, investigators and IRBs and on 27 March updated it.

Various challenges exist which result in restrictions of visits to healthcare facilities, increased demands on the health service and changes to trial staff availability. Participants may also be required to self-isolate, which introduces difficulties for Investigators to maintain their medical oversight. These challenges could have an impact on the conduct of trials, such as the completion of trial assessments, completion of trial visits and the provision of Investigational Medicinal Products (IMPs).

The impact of COVID-19 on ongoing trials, on opening a new trial site in an existing trial, ongoing recruitment and continued involvement of participants in the trial, or on starting of new trials needs to be considered. This evaluation should take into account national recommendations and restrictive measures including travel restrictions and confinements of trial participants and trial staff and the availability of trial staff to perform visits, enter data in the Case Report Form (CRF), notify serious adverse events and, more generally, follow the protocol. The ability to confirm eligibility and to conduct key safety assessments and trial evaluation is of particular importance. Actions should be proportionate and based on benefit-risk considerations, on contingency provisions taken nationally and locally by the authorities with priority given to the impact on the health and safety of the trial participant. Where a trial participant is unable to attend the site, other measures, such as home nursing, if possible given social distancing needs, or contact via phone or telemedicine means, may be required to identify adverse events and ensure continuous medical care and oversight. However, the limitations and risks of such methods and the requirements for data protection should be taken into account and such alternative arrangements need to be adequately documented.

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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
On 20 March 2020 the FDA announced the availability of this final guidance for industry.

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. The appendix to this guidance further explains those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.

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Guidance on Paediatric Submissions
On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.

It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. A letter of intent to submit a paediatric investigation plan (PIP) or a product specific waiver is no longer required nor processed.

Detailed guidance on creating the delivery file is to be found in User Guidance for submissions via eSubmission Gateway / Web Client using xml delivery files. All documents and zip files should be sent in a single folder as paediatric applications do not follow eCTD standards.

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Competitive Generic Therapies
On 13 March 2020 the FDA announced the availability of the final guidance for industry.

This guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy

(CGT) and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of abbreviated new drug applications (ANDAs) for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.

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510(k) Third Party Review Program
On 12 March 2020 the FDA issued the guidance for industry, FDA staff and third party review organizations.

The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. FDA’s implementation of section 523 establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P510k Review Program within the Center for Devices and Radiological Health (CDRH). This guidance document also reflects amendments made to section 523 by the FDA Reauthorization Act of 2017 (FDARA), which directed FDA to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person.

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Providing Regulatory Submissions in Alternate Electronic Format
On 10 March 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 11 May 2020.

This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These recommendations pertain to the format of content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).

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GCP Inspections: Expectations and the dos and don’ts for hosting
On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.

GCP inspections and how they are conducted has evolved over the years and has had to, due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology. No longer are trial teams based in one office with a paper trial master file (TMF). Inspections can be challenging for all involved and issues have often been encountered during the inspection conduct to do with TMF access and navigation, document request provision and sometimes simply finding the right person to answer a particular question. This can be frustrating for both parties and in some cases can lead to the extension of the inspection. It’s important to remember inspectors are only onsite for a short amount of time to understand your processes and procedures. The inspectors aren’t there to try and catch you out – it’s your opportunity to demonstrate your compliance to them. Inspectors will always be open and honest, and we expect the organisations we inspect to behave in the same way. The ultimate aim of both parties at the inspection is the same; to ensure trial participant safety and that new products are released based on robust data.

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Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
On 10 March 2020 the FDA announced that the agency halts routine inspections overseas through April due to coronavirus.

The FDA provided an update on the status of its inspections outside of the U.S. in response to the COVID-19 outbreak. After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

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China awards Gilead’s remdesivir patents, scolds local pharma over newsjacking
On 10 March 2020 GBI discussed China’s IP landscape and issues surrounding patent standards.

As one of the few therapies under development that could be beneficial as a treatment for the novel coronavirus-linked pneumonia COVID-19, Gilead Sciences Inc.’s remdesivir attracted the attention of local manufacturers early on during the outbreak. In February, the Shanghai-listed companies BrightGene Bio-Medical Technology and Materials Industry Zhongda Group separately announced that they had established manufacturing capabilities in relation to the remdesivir active pharmaceutical ingredient. Last week, the Shanghai Stock Exchange (SSE) issued reprimands against both companies for their opportunistic and misleading stock exchange announcements, since neither company has any commercial or intellectual property (IP) rights in relation to the drug.

The notifications will be welcomed by multinational pharma companies operating in China, and follows the China National Intellectual Property Administration (CNIPA) decision to award three patents for remdesivir, with five other patent filings still pending. Concerns had earlier been raised after the Wuhan Institute of Virology sought a China patent for remdesivir as part of a combination therapy specifically for COVID-19. GBI discussed China’s IP landscape and issues surrounding patent standards with Tony Chen, partner at Jones Day, in an exclusive interview published in CPB Review Volume 95. That interview is available to GBI SOURCE users via the Newswire page.

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Safety Testing of Drug Metabolites
On 5 March 2020 the FDA announced the availability of the final guidance for industry.

This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. Drug metabolites may need to be determined in nonclinical studies when they are disproportionate drug metabolites, that is, metabolites identified only in humans or present at higher plasma concentrations in humans than in any of the animal species used during standard nonclinical toxicology testing.

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ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
On 4 March 2020 the EMA published the Step 5 for ICH guideline Q12.

This guideline provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.

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