Top 3 Regulatory Hurdles
- SKRA
- Dec 2, 2023
- 2 min read
In world of pharmaceuticals, companies need to submit and undergo product registration process with the local regulatory authorities. The path to getting your pharmaceutical product on the market comes with challenges, often referred to as regulatory hurdles. These hurdles are critical checkpoints that ensure the safety, efficacy, and compliance of drugs. This article will explore the top three regulatory hurdles that pharmaceutical companies frequently encounter on their journey to regulatory approval.
1. Evolving Regulatory Guidelines
The pharmaceutical regulatory landscape is a continuously evolving environment. Keeping up with changes in regulations, guidelines, and standards across different regions is a formidable challenge. What may be acceptable today might not meet tomorrow's requirements.
What may be acceptable today might not meet tomorrow's requirements.
On top of the common harmonisation dossier, companies will also need to meet the country-specific regulatory requirements that can differ substantially from one country to another, e.g. the requirement for PICS Good Manufacturing Practice (GMP), Bioequivalence, reference countries approvals, stability, labelling, non-clinical, and clinical expectation.
This hurdle is particularly challenging for companies operating in various countries. Staying informed, proactive, and adaptive is essential to ensure compliance with ever-changing regulations.
2. Evaluation style
The specific evaluators and regulatory processes can vary depending on the type of pharmaceutical product (e.g., new drug, generic, biologic, medical device), so ensure you're looking for the correct information relevant to your product category.
... building a positive and collaborative relationship is crucial for a successful regulatory approval process
Effective communication with the local regulatory authorities responsible for evaluating pharmaceutical products and building a positive and collaborative relationship is crucial for a successful regulatory approval process. Gathering and following up on the response submission in meeting the regulatory deadline set by regulatory authorities can be a challenge for pharmaceutical companies. Failure to meet deadlines can delay the evaluation process and may result in the withdrawal of the applications.
3. Regulatory resources
Pharmaceutical regulatory resources challenges refer to the specific difficulties and
constraints that pharmaceutical companies encounter when allocating and managing resources to comply with the pharmaceutical industry's extensive and specialised regulatory requirements.
The preparation and compilation of the registration submission documentation are highly specialised tasks.
Post registration, continuous drug safety monitoring, adverse events reporting, pharmacovigilance activities and amendments to licence submission demand resources and expertise.
The preparation and compilation of the registration submission documentation are highly specialised tasks.
Attracting, retaining, and continually training such experts can be a resource challenge.
Conclusion
Successfully navigating these regulatory hurdles requires expertise, a deep understanding of the regulatory landscape, efficient and sufficient regulatory resources, and a commitment to patient safety.
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