The regulatory-HTA decision-making interface: What the medical writer should know - Volume 30, Issue

For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…

Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin - Volume 32, Issue

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…

Patient-reported outcomes: How useful are they? - Volume 26, Issue

Patient-reported outcomes (PROs) are any report on the status of a patient’s health condition as told by the patient him or herself or through an interview, without any interpretation by a clinician or anyone else. They generate information on those…

Clinical trial disclosure and transparency - Volume 27, Issue

The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…

Global perspectives on EDIB: Advancing equity, diversity, inclusion, and Belonging in medical communications - Volume 33, Issue

The integration of Equity, Diversity, Inclusion, and Belonging (EDIB) principles within the field of medical communications is of paramount importance. EDIB principles, aligned with global guidelines on sustainability – encompassing labour…

Good pharma - Volume 22, Issue

Drugs companies publish only a fraction of their results and keep much of the information to themselves. Drug companies are ‘debasing’ drug trials whose publication in journals can apparently confer scientific approval. Merck had fought for years to …

Regulatory writing basics - Volume 23, Issue

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The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…