A lifecycle of the new drug is very long, expensive, and complex which usually takes more than 10-12 years from product discovery to commercialization. Usually, the lifecycle of new drug comprises of main four stages, i.e., discovery, development, regulatory approval, and commercialization. Throughout the drug lifecycle, documentation is essential to give proof of the adherence of guidelines of good manufacturing practice (GMP) or regulatory authorities. Documents are considered as a final product of study as well as the source for regulatory authorities to check the safety and efficacy of the new treatment on human beings. In this article, we provide a complete list of regulatory documents at each stage of the drug development process with the required content and purpose.

drug life cycle

Figure 1: Essential documents required during drug life cycle

Documents Required in the Drug Lifecycle

The documents required during drug lifecycle are somewhat direct forms that should be completed with correct information; while some are more complex require experienced writer to handle. From simple to complex documents writing during each stage of drug lifecycle, well-skilled medical writers Medical writing play an important role to pull altogether the required information because they ensure each document is fit to meet the objective of the lifecycle of drug development, approval, and marketing authorization. Following points provide the deep insights into the key documents required at each stage of the drug life cycle;

Before Initiating the Clinical Study: Drug developer must submit investigational new drug application (IND) to the United States (US) health authority or investigational medicinal product designer (IMPD) to the European Union (EU) health authority for getting permission to run clinical studies on human subjects. This application contains manufacturing information, safety or toxicity data of animal studies, clinical study protocol for the scheduled clinical trial, and investigator data who will conduct the study. Following key documents are needed as per International Conference on Harmonization (ICH) E6 guideline to run a clinical study:

Investigator brochure (IB)

Clinical study protocol

Case report form (CRF)

Sample informed consent form (ICF)

Trial initiation monitoring report

Ethics approval documentation

During Clinical Study: When the clinical trial has been initiated, various documents need to update such as amendments required in the planned clinical study design in the form of change in objectives, number of participants, assessments, new investigators, new batches for the treatment, etc. Following key documents are required during the clinical study:

Clinical study protocol amendment

Development safety update reports (DSUR)

Investigator brochure update

Statistical Analysis Plan (SAP)

Signed Informed consent form

Logbooks

Interim or annual reports to IRB/IEC and authorities

After Completion of Clinical Study: Once the clinical trial has been completed, a descriptive clinical study report (CSR) must be written which provides detailed information about the safety and efficacy of the drug. Depends upon the clinical study, CSR can be a short (small phase 1 pharmacokinetic study), complex or long document (phase 3 study with various assessment factors). Including this, decoding documentation for blinded clinical study or origination of serious adverse event, trial close-out monitoring report (investigator submits a close-out letter to the Ethics Committee and sponsor), and clinical trial summary (must be submitted within one year of completion of the clinical study. The documents included for each study are:

Clinical study report

Clinical trial summary

Trial close-out monitoring report

Trial master file and archives

For Marketing Authorization: After completion of the clinical cycle, all summary documents are submitted as an application for market authorization, should be written as per guideline of the common technical document (CTD). The clinical part of CTD includes Modules 2.5: clinical overview and Module 2.7: clinical summary of biopharmaceutics, clinical pharmacology, clinical safety, and clinical efficacy. Apart from this, drug developer must have planned to monitor or minimise the potential risk associated with the drug. This plan submitted in the form of Risk Evaluation and Mitigation Strategies (REMS) document in the US or the Risk Management Plan (RMP) mandatory in the EU.

During Marketing: After getting marketing approval, there is need to publish gathered data during the clinical study to provide awareness about the benefits and risk of the new drug to the health authority, health practitioner, physicians, and patients. Including this, health authority requires more safety data after drug approval in the market; for this, drug developer conducts post-marketing clinical studies (phase 4) to provide safety data within the given time to the regulatory authority. Safety data can be collected in the form of the periodic benefit-risk evaluation report (PBRER) or Periodic Safety Update Report (PSUR); this is known as pharmacovigilance cycle. Risk management plan (RMP) update also submitted to authority if any risks associated with the marketed drug are being assessed. The other documents included are:

Abstracts

Manuscripts

Posters

Publication

Patient information sheets

Patients advice sheet

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