The development and approval of medications for children is a critical aspect of pediatric healthcare. However, due to ethical and practical considerations, clinical trials involving children are often limited. As a result, pediatric drug labeling plays a crucial role in ensuring the safe and appropriate use of medications in this vulnerable population.
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.
The pharmaceutical industry operates in a highly regulated environment, with stringent labeling requirements and information dissemination. As pharmaceutical companies strive to meet the diverse needs of patients and healthcare professionals, managing labeling for multiple product variants becomes a critical task.
In this blog, we shall explore the significance of harmonizing labeling for multiple product variants in the pharmaceutical industry and the strategies companies can adopt to ensure safety, compliance, and optimal patient outcomes.
The annotated labeling document is a Regulatory requirement that needs to be submitted along with New Drug Applications (NDAs)/Abbreviated New Drug Applications (ANDAs)/new Marketing Authorization Applications (MAAs). This blog will give you an overview of the requirements for developing an annotated labeling package.
A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.
The COVID-19 pandemic has brought about unprecedented changes in the healthcare industry, including the Pharmacovigilance (PV) process. The pandemic re-emphasized the role of PV in the pharmaceutical industry. As personalized medicine gained popularity, the tactics of pharmaceutical manufacturers and the PV process flow for ensuring the end-user’s safety had to alter. The drug/Medical Devices & Vaccines (MDV) manufacturers faced more challenges as the market transitioned towards personalized medicine, which led to an alignment with new trends and technologies.
Abbreviated SmPCs (Summary of Product Characteristics) form an important source of information for healthcare professionals and patients alike. These documents provide a summary of key information about a medicinal product, including its indications, posology, contraindications, and adverse reactions.
Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.
Summary of Product Characteristics (SmPC) is a medical monograph created and updated by pharmaceutical companies based on product research and knowledge. It offers much more than a structured list of vital information on each drug, such as fixed dosage and potential side effects. Pharmacists, doctors, nurses, and other healthcare professionals rely on this data to appropriately prescribe medications and educate their patients about medicinal product use.