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Jan 31, 2020

Electronic product information for human medicines in the EU: key principles
On 29 January 2020 the EMA published the key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the EU.

The key principles describe the benefits ePI can deliver for public health and the efficiencies it may introduce in regulatory procedures. They explain how ePI will comply with the existing legislative framework: it will be provided as open access information that complements the paper package leaflet. They also outline a flexible, harmonised approach to implementation across the EU, and describe how ePI will work in the EU’s multilingual environment and will interact with other ongoing digital initiatives at EU and global level.

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EMA supporting small and medium-sized enterprises (SMEs)
On 28 January 2020 EMA updated supporting SMEs.

EMA invites SMEs and interested stakeholder organisations to complete a short survey by 10 March 2020 to help EMA understand their current challenges and tailor its future activities to their needs.

The EMA addresses the unique needs of micro, SMEs through the SME office. This dedicated interface has the sole remit of providing regulatory, financial and administrative assistance to small pharmaceutical companies.

It was set up by Commission Regulation (EC) No 2049/2005 and promotes innovation and the development of new medicines for human and veterinary use by SMEs.

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FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
On 28 January 2020 FDA announced that it continues its efforts to support innovators developing gene therapy products.

To date, the FDA has approved four gene therapy products, which insert new genetic material into a patient’s cells. The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices.

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Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
On 24 January 2020 FDA announced the availability of the final guide for industry.

This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies.

The use of MRD as a biomarker in drug development is distinct from FDA’s requirement for investigating, clearing, or approving an in vitro diagnostic device for clinical use in measuring MRD. Manufacturers interested in developing a specific MRD assay for clinical use should consult the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health (CDRH).

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Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
On 23 January 2020 FDA announced the availability of the final guide for industry.

This guidance provides stakeholders information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. Because BsUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

This guidance describes the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment. This guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. This guidance does not address how FDA determines and adjusts fees each fiscal year; nor does it address FDA’s implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, Generic Drug User Fee Amendments). Throughout this guidance, references to user fees or the user-fee program are to the user fee program for biosimilar biological products under section 744H of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers
On 23 January 2020 FDA informed potential cybersecurity vulnerabilities of certain GE Healthcare Clinical Information Central Stations and Telemetry Servers

The FDA is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers. These devices are primarily used in health care facilities for displaying patient information, such as the physiologic status (i.e., temperature, heartbeat, blood pressure, etc.) of a patient, and monitoring patient status from a central location in a facility, such as a nurse’s bay. The cybersecurity vulnerabilities identified could allow an attacker to remotely take control of the device to silence alarms, generate false alarms or interfere with the function of patient monitors connected to these devices. For example, an attacker could potentially silence an alarm that is intended to communicate vital information about a patient to health care staff, such as a patient’s cardiac status. These cybersecurity vulnerabilities were identified by a third-party security firm. To date, the agency has not received any adverse event reports, including reports of patient harm or device malfunction, associated with these vulnerabilities.

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Procedural advice for orphan medicinal product designation
On 21 January 2020 EMA updated this guidance for sponsors.

The legislation on orphan medicinal products, Regulation (EC) No 141/2000 of the European Parliament and of the Council, was adopted on 16 December 1999 and published in the Official Journal of the European Communities on 22 January 2000 (Ref. L18/1). This Regulation lays down a Community procedure for the designation of medicinal products as orphan medicinal products and provides incentives for the development and placing on the market of designated orphan medicinal products. The Regulation also establishes the Committee for Orphan Medicinal Products (COMP) within the EMA, which is responsible for examining applications for orphan medicinal product designation.

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Ten recommendations to unlock the potential of big data for public health in the EU
On 20 January 2020 the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposed ten priority actions for the European medicines regulatory network.

In January 2020, the HMA/EMA Task Force on Big Data published its final report (phase two) containing practical recommendations on how the European medicines regulatory network could make best use of big data by evolving its approach to data use and evidence generation in support of innovation and public health.

The report aims to inform strategic decision-making and planning by the HMA and EMA and to input to the EU Network Strategy to 2025. The report will support regulators and stakeholders seizing the opportunity for data- driven, evidence-based, robust decision-making that will underpin the development, authorisation and on-market safety and effectiveness monitoring of medicines in a rapidly evolving data and analytics landscape.

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