1. Introduction The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing clinical trials within the Regulation. The draft document has been submitted for discussion to the Expert Group on Clinical Trials.
1. Introduction The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data electronically by investigator site staff at the point of care. In its opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) does
On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM). The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will
The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The draft Opinion was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP). It presents CHMP’s views on the “regulatory acceptability” of eSource
The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced therapy medicinal products (“ATMPs”). The purpose of the Guidelines is to adapt existing good clinical practice rules (“GCPs”) to ATMPs. This step
This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease categories (hemophilia, rare diseases, and retinal disorders), and three of which address manufacturing and clinical study design issues related to gene therapy: chemistry, manufacturing and control (CMC) information in
The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor. The updated Guideline, issued in the form of a Q&A document, provides that
In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and examines the specific ethical and scientific considerations that may impact this decision.
On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the future (so-called advanced decision, sometimes also referred to as living will, and translated as “Biotestamento” in Italian ). Advanced decision of
Fast track for orphan diseases and rare forms of cancers By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new rules on expanded access to medicinal products, for which the authorisation procedure is still on-going, replacing the former Ministerial
On July 25, 2017, FDA issued a guidance document implementing a policy which allows IRBs to waive general informed consent requirements for minimal risk studies, similar to the waivers allowed under the Common Rule.
The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by the CHMP on 20 July 2017. It will come into effect on 1 February 2018. The revised Guideline is the outcome of EMA’s
In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures (MAPP) outlining the Office’s policy goals, roles, and responsibilities with respect to financial disclosures in NDAs, BLAs and NDA/BLA supplements.
In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare professionals and payers regarding personalised medicine. During the workshop future challenges and related actions, that should be taken regarding personalised medicine, were identified. The challenges
On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug,
Digital health technologies, including healthcare apps, have the potential to offer alternative healthcare pathways and, if utilised correctly, have the power to transform healthcare. But do healthcare apps risk being defeated by a lack of patient engagement?
On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.
The Court of Justice of the European Union declares invalid the European Commission’s Safe Harbor Decision and its implications on the transfer of clinical data to the U.S On 6 October 2015, the Court of Justice of the European Union (“CJEU”) ruled that the European Commission Decision on the adequacy of the EU-U.S Safe Harbor
On Friday the National Institutes of Health (NIH) published an extensive proposed rule, intended to clarify and expand the requirements for submission of clinical trial registration and results information to the ClinicalTrials.gov data bank. See 79 Fed. Reg. 69,566 (Nov. 21, 2014). The rulemaking proposes to add a new Part 11 to Title 42 of the CFR to implement the statutory requirements set forth in section 402(j) of the Public Health Service Act (PHSA). Section 402(j) had been added to the statute by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
On July 15, 2014, the Food and Drug Administration (FDA or the Agency) announced a new Draft Guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.