Staying compliant with regulations is essential, and it is becoming increasingly difficult for organizations as Regulatory expectations continue to evolve and are sometimes specific to Regulatory Medical Writing or particular programs. This is often challenging for organizations with relatively less Regulatory experience that they have gathered from occasional submissions and for those working on entirely new therapeutic areas with innovative treatment modalities and approaches, including novel delivery technologies.
In the pharmaceutical industry, adhering to Chemistry, Manufacturing, and Controls (CMC) requirements is paramount for ensuring the safety and efficacy of drugs. However, Regulatory agencies often identify gaps or deficiencies in the CMC data submitted by companies, which necessitates remediation.
This blog explains the indispensable role of Regulatory staffing solutions in successfully navigating CMC remediation while also shedding light on effective portfolio management practices.
Regulatory Affairs (RA) play a pivotal role in ensuring drug products’ safety, efficacy, and quality in the dynamic pharmaceutical landscape. Chemistry, Manufacturing, and Controls (CMC) RA is essential for compliance. It aims to safeguard patient health and promote public confidence in pharmaceutical products by ensuring consistency and quality throughout the drug manufacturing process.
Over the years, procedures for assembling and filing eCTD submissions have evolved tremendously. Non-adherence to the submission requirements may occur when documents are not relevant to fit seamlessly into the given eCTD format. In such scenarios, applicants are burdened with making last-minute amendments, which cause a delay in submission or, in an extreme case, a technical rejection of the entire submission.
Pharmaceutical companies can thrive in South Africa owing to the legislative framework for regulation of medicines and a burgeoning market for unmet medical need among sufferers of HIV/AIDS and those inflicted with other infectious diseases. If drug companies intend to take advantage of the market opportunity and deliver medicines to patients, they must firstly focus on the effective lifecycle management of medicinal product registrations.
Drug Master File (DMF) is one of the important parts of the documents submitted to the regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW).
What is Drug Master File (DMF)