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07 April 2021
The research and development (R&D) of medicinal products is important both from an individual perspective, considering its objective to identify and treat pathologies (with the consequent improvement in patients' quality of life), and from a collective perspective, considering its role in controlling the spread of diseases or eradicating them altogether.
'R&D activities' can be defined as activities carried out in humans (who may be healthy or ill) to:
R&D activities are subject to legal and regulatory frameworks and practitioners must comply with various requirements, including:
Clinical trials are a universally recognised method of performing R&D activities. They must be planned and controlled meticulously to ensure the scientific validity of the results.
In Portugal, clinical trials are governed by Law 21/2014 of 16 April 2014 (amended by Law 73/2015 of 27 July 2015 and Law 49/2018 of 14 August 2018), known as the 'Clinical Research Law' ('CRL'). The CRL includes:
The CRL defines a 'clinical trial' or 'trial' as:
any research conducted into human beings, intended to discover or confirm the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or to identify the undesirable effects of one or more investigational medicinal products, or to analyse the absorption, distribution, metabolism and elimination of one or more investigational medicinal products, in order to ascertain their safety or efficacy.
In Portugal, conducting a clinical trial is subject to:
The sponsor (ie, the natural or legal person, institute or entity responsible for the design, conduct, management or financing of the clinical trial) must submit its applications to the CEC and INFARMED, respectively, through the National Clinical Trials Register's online platform.
Subject to certain situations provided for by law, the CEC must opine within 30 business days and state its position on various aspects of the application submitted by the sponsor, including:
Except in situations that require express authorisation as set out below, once the CEC has issued its approval, INFARMED's governing board must decide on the application within 30 business days. However, during that period, the board can request any additional documents, information or clarification which it considers necessary. The above period will be suspended until any such request is properly answered.
INFARMED can also present any well-founded objections to an application for authorisation which, in its opinion, could prevent the application's approval. Under these circumstances, the sponsor may change the application. It may do so only once and must do so within the period granted by INFARMED.
If INFARMED considers the change to be insufficient or if the sponsor chooses to make no change to the initial application, the application will be rejected and the clinical trial may not be conducted.
After a clinical trial begins, the sponsor may change the corresponding protocol, provided that it performs a prior assessment to ensure that the potential benefits continue to outweigh the foreseeable risks and inconveniences. However, no changes may be made if they would harm the subjects' safety or change the interpretation of the scientific evidence on which the trial is based.
To change the protocol, the sponsor obtain the CEC's permission. The clinical trial may proceed only:
If the CEC approves the change but INFARMED objects, the trial may proceed only if the protocol is adapted to address the objections or if the proposed amendment is withdrawn.
Unless the end of the clinical trial is brought forward, the sponsor must notify the CEC within 90 days of the end of the last subject's participation in the trial. The investigator or sponsor must also provide the CEC with the results of the trial in the form of a summary of the final report.
The COVID-19 pandemic has made clinical trials even more important, particularly to bring effective drugs to combat the disease to the market as soon as possible. The pandemic has put the scientific community and the pharmaceutical industry under pressure to design medicinal products that quickly, safely and effectively control its spread. Therefore, the European Medicines Agency has called for:
INFARMED has published various measures which aim to mitigate the risks that the pandemic may pose to patients who participate in clinical trials, including:
In this context, INFARMED allows sponsors to change the terms of their clinical trial authorisation to ensure the safety and protection of their subjects without requiring prior notification or approval. However, this does not apply to cases where treatment is interrupted, which must be notified to INFARMED as an urgent safety measure.
The sponsor – in conjunction with the investigator and based on a risk analysis – must assess and adopt measures to mitigate the risk of contamination for each clinical trial, considering:
The sponsor must notify INFARMED within four months where any of the above measures are taken. This notification must be accompanied by:
However, in cases which involve substantial changes that do not require immediate intervention by the investigator and sponsor, the sponsor must submit these to INFARMED as substantial changes through the usual procedure.
For further information on this topic please contact Eduardo Finamore Correia or Ricardo Rocha at PLMJ by telephone (+351 213 197 300) or email (firstname.lastname@example.org or email@example.com). The PLMJ website can be accessed at www.plmj.com.
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