Clinical Trial Regulation, ICH E6(R2), Brexit and much more feature in our Q1 Industry Update, compiled by Christina Hägglund, QA Manager S-cubed Ltd. Read all the latest regulatory news here.

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REGULATIONS

Clinical Trial Regulation: EU No 536/2014

The European Medicines Agency (EMA) has provided a brief update on the development and testing of the centralised EU portal and database (the Clinical Trials Information System (CTIS)). Although there has been progress, there is still no scheduled date for the CTIS audit or a ‘go-live’ date. Follow our updates on this regulation and others by signing up for our newsletter.

Questions 1.7, 2.8 and 5.2 of the draft Q&A document (version 2.3, November 2019) have been added or revised.

ICH E6(R2)

When a Guideline reaches Step 5, it has been both accepted and implemented into national or regional legislation. ICH has recently shown that for E6(R2) guideline, different countries have implemented it at different times – the EC, Switzerland, Singapore and China were early adopters, but the guideline was only implemented in March 2018 and November 2019 respectively for USA and Brazil.
An Expert Working Group is now working on revisions to the ICH E6(R2) GCP Guideline. The ICH E6(R3) concept paper and business plan are available on the ICH website.

Brexit

During the transition period, which runs until 31 December 2020, EU pharmaceutical law will continue to apply in the UK.
Since 01 February 2020 the UK has not participated in EU institutions or in their decision making, this includes EMA scientific committees, working parties and Management Boards.
By the end of the year, companies must make the necessary changes to ensure their authorised medicines comply with EU law and can remain on the EU market. Updated Brexit-related guidance for companies will be published on the EMA website shortly.

New Guidance for Medical Device Trials

The International Medical Device Regulators Forum (IMDRF) has released three final technical documents on evaluating medical devices:

China – Reform and New Drug Law

Reforms to the Drug Administration Law were considered necessary because of the increasing gap between the previous legislation and current expectations for drug safety.
On 01 Dec 2019, new legislation came into effect which is overseen by the National Medical Products Administration (formerly the China Food and Drug Administration).

PHARMACOVIGILANCE AND SAFETY REPORTING

Mandatory Use of International Standards for Safety Reporting

On 15 January 2020, the EMA indicated that the new ISO individual case safety report format (based on the ICH E2B(R3) Guidelines) will become mandatory from 30 June 2022 for all reporting to EudraVigilance.

EU PV Activities between 2015 and 2018

The EMA has published a report which describes pharmacovigilance activities carried out by the national competent authorities of the EU Member States, Norway, Iceland and by the EMA, which also acts as the coordinating body of the EU pharmacovigilance system.

INVESTIGATIONAL PRODUCT TO MARKET

NHS – Fast-Track of Certain Cancer Drugs

There are specific new cancer drugs that targets the tumour according to genetic makeup rather than tumour location. The NHS plan to fast-track these to the market, as each offers the advantage of being suitable for use against a range of cancers.

French Regulator to Retain Fast-Track Programme

In October 2018, the French regulatory Agency set up two Fast-Track programmes (‘circuits’) primarily for areas such as paediatric oncology, haematology and rare diseases. After a successful test phase, the Agency has decided to maintain its two accelerated circuits.

DATA PROTECTION AND PATIENT CONFIDENTIALITY

Brexit and the General Data Protection Regulation (GDPR)

During the Brexit transition period, the GDPR will continue to apply in full in the UK.

North London Pharmacy Fined for Infringing the GDPR

The Information Commissioner’s Office considered the pharmacy to have failed in its obligation to process data in a manner that ensures appropriate security against unauthorised or unlawful processing, and accidental loss, destruction or damage. The pharmacy left numerous documents containing personal data in unlocked containers at the back of its premises.

FDA Issues Draft Guidance on Research Participant Confidentiality

The FDA has issued new draft guidance on Certificates of Confidentiality for human research participants. The Certificates will now provide a broader protection by prohibiting holders from disclosing identifiable sensitive data unless a specific exception applies.

FINAL AND DRAFT GUIDANCE DOCUMENTS

EMA

FDA

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