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Clinical Trial Transparency and Disclosure Regulations
EMA Policy 0070 is a policy developed by the European Medicines Agency (EMA) for the publication of clinical data for human medicines. Since 2015, the policy requires the proactive publication of clinical data submitted by pharmaceutical companies as part of marketing authorization applications or post-authorization procedures.
The aim of the policy is to increase transparency in the development and evaluation of medicines, and to promote the sharing of clinical trial data in order to benefit public health. Under the policy, clinical data for approved medicines must be published on the EMA's clinical data website, following the approval of the medicine.
The policy sets out the scope and requirements for the publication of clinical data, as well as the procedures for accessing and using the data. It also includes provisions for protecting patient confidentiality and for managing requests for additional information or analysis.
Overall, EMA Policy 0070 represents a significant step towards greater transparency in the development and evaluation of medicines, and reflects the growing recognition of the importance of data sharing in advancing medical research and improving patient outcomes.
If you are a pharmaceutical company that has submitted clinical data as part of a marketing authorization application or post-authorization procedure for a human medicine in the European Union, you will need to comply with EMA Policy 0070 for the publication of clinical data. Here are some steps to help you comply with the policy:
Overall, complying with EMA Policy 0070 requires careful planning and preparation, as well as a commitment to transparency and data sharing in the development and evaluation of medicines. It is important to ensure that your data is prepared and submitted in a way that meets the requirements of the policy.
Data anonymization plays a critical role within EMA Policy 0070. The policy requires that all clinical data submitted for publication must be anonymized to protect patient privacy and confidentiality. Anonymization involves transforming or redacting information that could be used to identify individual patients, such as names, addresses, gender, dates of birth, and other personal information.
The EMA has developed specific guidelines for the anonymization of clinical data, which include use of a risk-based approach to determine the level of anonymization required based on the sensitivity of the data and the risk of re-identification. The guidelines also provide detailed instructions for how to carry out the anonymization process, including the recommended use of software tools and manual review to ensure that all identifying information has been transformed or removed.
By requiring the anonymization of clinical data, EMA Policy 0070 aims to protect patient privacy and confidentiality, while still enabling the sharing of clinical trial data for the benefit of public health. Anonymization also helps to promote trust in the research process by ensuring that patients' personal information is kept confidential and secure.
Overall, data anonymization is a critical component of EMA Policy 0070, and is essential for ensuring that clinical trial data can be shared in a responsible and ethical way that protects patient privacy and confidentiality.
EMA Policy 0070 and the General Data Protection Regulation (GDPR) have some similarities, but they are different in scope and purpose.
EMA Policy 0070 specifically applies to clinical trial data submitted to the EMA for regulatory purposes. The policy requires that clinical data submitted for publication must be anonymized to protect patient privacy and confidentiality. The policy also provides specific guidance on how anonymization should be carried out and the level of anonymization required.
While EMA Policy 0070 is specific to clinical trial data submitted to the EMA for regulatory purposes, GDPR applies to all personal data processed within the European Union. GDPR requires that personal data be collected and processed in a lawful, fair, and transparent manner, with appropriate technical and organizational measures in place to ensure the security and confidentiality of personal data.
Overall, EMA Policy 0070 and GDPR both aim to protect the privacy and confidentiality of personal data, but they differ in their scope and specific requirements. While EMA Policy 0070 focuses specifically on clinical trial data submitted to the EMA, GDPR applies more broadly to all personal data processed within the European Union.
Both EMA Policy 0070 and the EU Clinical Trials Regulation (CTR) share a common goal of promoting transparency and public access to clinical trial data. Here are some similarities between the two:
EMA Policy 0070, also known as the "Policy on the Publication of Clinical Data for Medicinal Products for Human Use," was introduced by the European Medicines Agency (EMA) to enhance transparency and promote the availability of clinical trial data. Under this policy, the EMA publishes clinical data submitted by pharmaceutical companies as part of marketing authorization applications for new medicinal products.
EMA Policy 0070 enables public access to clinical study reports (CSRs), which contain detailed information on the methods, results, and analysis of clinical trials. The policy aims to foster scientific research, enable independent scrutiny of clinical data, and contribute to public health knowledge.
On the other hand, the EU Clinical Trials Regulation (CTR) is a regulation adopted by the European Union in 2014, which is intended to streamline and harmonize the regulation of clinical trials across the EU member states. However, as of my knowledge cutoff, the CTR has not yet come into full effect.
The CTR aims to simplify the process of conducting clinical trials in the EU by establishing a centralized system for the authorization and oversight of trials. It introduces several changes, such as a single submission portal, simplified reporting procedures, and increased transparency in clinical trial information.
While EMA Policy 0070 focuses on the publication of clinical data by the EMA, the EU Clinical Trials Regulation encompasses a broader set of regulations governing the conduct of clinical trials within the European Union. It aims to improve the efficiency and transparency of the clinical trial process while ensuring the safety and rights of trial participants.
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