October 2021: Voluntary Harmonisation Procedure Update

Update from Heads of Medicines Agencies (HMA) on the Conclusion of Voluntary Harmonisation Procedure (VHP)

The full implementation of the new Clinical Trials Regulation 536/2014 is planned for January 31, 2022. Therefore, all voluntary harmonisation procedures (VHP) are planned to be finalized in January 2022. In order to organize a smooth transition of the VHP processes into CTIS and the CTR, the last day for any VHP submission is October 15, 2021. Submission after the deadline (15 October midnight) will not be accepted without further notice (neither initial application, nor substantial amendment nor addition of Member State).

VHP is voluntary and applies to multi-national clinical trials conducted in the EU. It allows the sponsor to submit a single clinical trial application at once to 2 or more national competent authorities in the EU. The Heads of Medicines Agencies (HMA) is a network of the heads of the national competent authorities, the agencies responsible for the regulation of human and veterinary medicines in the individual countries of the European Economic Area (EEA). Additional information can be found here.

May 2021: Taiwan Regulatory Update

The “Medical Devices Act” has come into effect from May 01, 2021. This act was announced on January 15, 2020 under the Presidential Decree. Taiwan Food and Drug Administration (TFDA) has amended the Pharmaceutical Affairs Act and stipulated a new law specifically for the management of medical devices. More information is available here.

March 2021: Taiwan Regulatory Update

The new “Medical Devices Act” is set to come into effect on May 01, 2021. This law was announced on January 15, 2020. Earlier medical devices were regulated by the Pharmaceutical Affairs Act, but now they will be part of the Medical Devices Act. Details about clinical trials on medical devices are included in Chapter IV, Article 37-39.

Medical device clinical trials conducted in Taiwan need prior approval from the Taiwan FDA. Sponsors will need to report any serious or life-threatening adverse events related to medical device clinical trials conducted in Taiwan. Even though the regulation includes a generic term called ‘information disclosure’, it has not been elaborated further.

June 2020: Taiwan Regulatory Update

Applications for participating in TCP III is still being accepted

June 30, 2020: Application for participating in the Technical Cooperation Programme, Version 3.0 (TCP III) on exchange of medical device quality management system(QMS) regulation and ISO 13485 audit reports is still being accepted.

The submission of application for participating in the Technical cooperation Programme (TCP) on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports between EU MDR/IVDR Notified Body Partners and R.O.C. Taiwan Food and Drug Administration (TFDA) Authorized Medical Device QMS Auditing Organizations, Version 3.0 (Known as TCP III) was open since 21st November, 2019.

Any notified body designated under EU MDR/IVDR is interested to participate in the TCP III, a submission of application for participating in TCP III is still welcome.

Overview of Taiwan’s regulatory system

As per the provisions under the Taiwan’s Pharmaceutical Affairs Act, a pre-market approval of medical devices is necessary prior to market entry in Taiwan. A Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration (exempted for Class I [non-sterile] medical devices) that meets Taiwan’s good manufacturing practice (GMP) requirements.

What is TCP?

In order to streamline the product registration process for medical devices that have received prior EU approval, the Republic of China (R.O.C.) Taiwan Food and Drug Administration (TFDA) Authorized Medical Device GMP Auditing Organizations and EU Medical Device Regulation(MDR)/ In-vitro Diagnostic Regulation (IVDR) Notified Body Partners have entered into a Technical Cooperation Program (TCP). It enables independent third-party organizations partnered with TCP to issue ISO 13485 certificate and audit report to TFDA on behalf of the  medical device manufacturers (located in EU) thereby replacing the requirement to submit QMS and easing the medical device registration process in Taiwan.

The first stage of assessment process including its qualifications and quality management system review is in progress. All applicants need to go through the second stage assessment (including on-site auditing and witness audits) before successfully becoming a partner of TCPIII. An EU MDR/IVDR Notified Body could successfully become a partner of TCP III once the assessment was completed and get the agreement signed.

May 2020: Taiwan Regulatory Update

Technical Cooperation Programme, Version 2.0 (TCP II) remains valid until 2021

May 14, 2020: Technical Cooperation Programme, Version 2.0 (TCP II) on exchange of medical device quality management system regulation and ISO 13485 audit reports remain valid until 2021.

Owing to COVID-19 situation, the on-site auditing and witness audits are waiting for arrangements based on overseas travelling constraints.

Currently, the Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 13485 Audit Reports between EU AIMD/MDD/IVDD Notified Body Partners and R.O.C. TFDA Authorized Medical Device GMP Auditing Organization, Version 2.0 (Known as TCP II) remains valid.

In response to the forthcoming regulations on Taiwan Medical Devices Act and new application date for the new European Medical Device Regulation (MDR) announced by EC, the TCP II is expected to upgrade to TCP III by 25 May 2021.

Overview of Taiwan’s regulatory system

As per the provisions under the Taiwan’s Pharmaceutical Affairs Act, a pre-market approval of medical devices is necessary prior to market entry in Taiwan. A Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration (exempted for Class I [non-sterile] medical devices) that meets Taiwan’s good manufacturing practice (GMP) requirements.

What is TCP?

In order to streamline the product registration process for medical devices that have received prior EU approval, the Republic of China (R.O.C.) Taiwan Food and Drug Administration (TFDA) Authorized Medical Device GMP Auditing Organizations and EU Medical Device Regulation(MDR)/ In-vitro Diagnostic Regulation (IVDR) Notified Body Partners have entered into a Technical Cooperation Program (TCP). It enables independent third-party organizations partnered with TCP to issue ISO 13485 certificate and audit report to TFDA on behalf of the  medical device manufacturers (located in EU) thereby replacing the requirement to submit QMS and easing the medical device registration process in Taiwan.

The first stage of assessment process including its qualifications and quality management system review is in progress. All applicants need to go through the second stage assessment (including on-site auditing and witness audits) before successfully becoming a partner of TCPIII. An EU MDR/IVDR Notified Body could successfully become a partner of TCP III once the assessment was completed and get the agreement signed.

March 2020: Estonia Guidance on Clinical Trial Management in the Context of COVID-19 Pandemic

The Government of Estonia has declared an Emergency Situation until 1 May, 2020 due to the pandemic of COVID-19.

The State Agency of Medicines (SAM) has issued a guidance document on the management of clinical trials in Estonia during the COVID-19 situation.  The guidance is in effect until the end of the emergency situation and will be updated as the situation progresses.

Any reported changes to the trial conduct must be specific and applicable to Estonian study sites and Estonian trial subjects. General descriptions of possible measures that may or may not be used in Estonia are not accepted. Continue reading “March 2020: Estonia Guidance on Clinical Trial Management in the Context of COVID-19 Pandemic”