Overview

Pharmaceutical industry is rapidly growing across the globe. Being a crucial segment of the Life Sciences industry, it deals with innovation and development of lifesaving drugs. The Pharmaceutical Regulatory Affairs team is the primary communication link between the company and the global Health Agencies such as FDA, Health Canada, MHRA, etc.

Ageing population, increasing income, changing lifestyle, and an increasing number of chronic diseases are among the few key factors leading to the growth of the Pharmaceutical industry. These factors, combined, call for improved medication, which in turn would lead to drug innovation.

Innovation in the context of a medicinal product involves multiple critical phases. Right from identifying a lead compound (in the process of drug discovery) to ensuring that the end product is safe and effective for the end user; the process typically looks as follows:

  • Discovery and Development: Research and testing of molecular compounds and new technologies followed by the development of a new drug in the laboratory.
  • Pre-clinical Phase:  Pre-clinical research is mainly conducted on microorganisms and animals for answering basic questions about drug safety.
  • Clinical Research: Drug testing on people, which is further divided into Phase I, II, III & IV of clinical trials.
  • Health Authority (HA) Review: HA review team thoroughly examines the data submitted by manufacturers’ Pharma CMC department for drug registration and decides whether to approve or reject the end product.

Drug Classification

  • Innovator/Brand-name Drugs and Generic Drugs

While an innovator drug, one that has a trading name, is protected by a patent and can be produced and sold by the company holding the patent, a generic drug is an equivalent to an innovator in terms of dosage, strength, route of administration, quality, performance and intended use and costs almost 30-80% lesser. The Pharmaceutical Regulatory affairs/ Pharma CMC wing of the manufacturer has to submit documentation attesting this equivalence in safety and efficacy to the HA for approval. When the patent protection for an innovator drug expires, generic versions of the drug can be offered for sale in consent with concerned HAs.

  • Prescription Drugs and Over-The-Counter (OTC) Drugs​

While a prescription drug can be availed only when a pharmacist dispenses it on the order of a physician or physician assistant or qualified nurse, an OTC can be ordered and consumed by consumers themselves. 

Pharma Industry Regulatory challenges

A drug developed and marketed by a pharmaceutical company should promote safe and better health. Considering its tedious development process and different classifications, there might be deviations in establishing patient safety without any trackers or validations. Hence there is a plethora of laws and regulations to govern the testing, patenting, safety, and efficacy while marketing. To do so, HAs worldwide overlook and ensure the best practices put forward.

                    

With many of their drugs are in various stages of lifecycle (development, yet-to-be-marketed and global expansion), Pharma companies and their Pharmaceutical Regulatory Affairs departments may face challenges in the context of CMC and Regulatory activities aligning with market standards for necessary drug registrations, approvals and compliant market-entry. The challenges include:

  • Tracking down various region-specific HA regulations pertaining to:
    • Quality and Assurance
    • GxP Practices
    • Audit and Validation
    • Lifecycle Management
    • Pharma CMC
    • Dossier Compilation
  • Pharmaceutical Regulatory Affairs Procedural Complexities
    • Publishing and Submission
    • Dossier Preparation
    • Labeling, Artwork Design and Pack Management
    • Medical Writing
  • Aligning with and Meeting Mandatory Deadlines
  • Lack of In-house Regulatory Affairs Personnel

Freyr for Regulatory needs of Pharma Industry

As a proven Regulatory Affairs partner for renowned pharmaceutical companies worldwide, Freyr assists manufacturers to navigate the global Pharma Regulatory regime to standardize procedures, centralize systems and streamline Regulatory submissions for drug classifications, drug registrations, licensing and obtaining market approvals with Industry LeadingTAT. Freyr, with a specialized focus on the entire Pharmaceutical Regulatory Affairs value-chain, provides cost-effective Regulatory solutions and services. We customize the process with respect to service and software assistance for end-to-end drug approvals & Regulatory CMC Support.

With a widely distributed consultant network, Freyr offers a path to approval across multiple jurisdictions.