Regulatory Services in Kenya
Kenya
The Pharmacy and Poisons Board (PPB) is a government body that oversees the manufacture, regulation, and trade of medicines and poisons in Kenya. It implements the necessary regulatory measures as per the Pharmacy and Poisons Act Laws to guarantee public access to safe, efficacious, and high-quality medicines. In 2010, the PPB adopted the more stringent CTD format, that is recognized by the World Health Organization (WHO) which requires more comprehensive drug-related safety, efficacy, and quality information. Thus, as a member of the East African Community (EAC), Kenya is positively driving global regulatory harmonization and setting an example for other EAC members. However, the implementation of the more stringent CTD form has also led to a decline in the number of product registrations in Kenya, as local manufacturers are unable to provide the necessary information that is required. As a result, there are more unregistered products that are not compliant with the Good Manufacturing Practice (GMP) in the Kenyan market which is burdening and overstretching the PPB.
As a leading global contender, DDReg’s regulatory services in Kenya provide ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management
- QPPV Services
- Bio Waiver Justifications
- Clinical & Non-Clinical Experts Reports
- IPR Support, including Worldwide Patent Status and Patent Reviews