ROW refers to the rest of the world countries, also known as the semi-regulated market. These regions consist mainly the countries form Asia Pacifica, South Africa, Latin America and Middle East.
Global pharma market is broadly divided into following two categories:
1. Regulated Market:
US, EU (UK, Germany, France, Ireland, S.eden etc.), Japan, Canada, Brazil, Australia, South Africa.
2. Semi regulated Market (also called ROW market):
(a) Asia: Sri Lanka, Pakistan, India, Bangladesh; ASEAN: Philippines, Vietnam Singapore, Malaysia, Thailand, Indonesia, Laos, Cambodia, Brunei Darussalam, Myanmar.
(b) Africa: Algeria, Zambia, Ethiopia, Ghana, Kenya, Namibia, Nigeria, Tanzania, Zimbabwe etc.
(c) Middle East (Gulf Co-operation Council countries): Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE
(d) Latin America: Mexico, Panama, Peru, Guatemala, Argentina, Chile, Dominican Republic.
(e) CIS (common wealth of independent states): Russia, Ukraine, OFSUs (Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan etc.).
The major differences between regulated and semi-regulated market are the degrees implementation of regulations and the intensity of audits/ inspections.
In ROW market, different countries have different requirements and it is difficult for any company to develop a product for each region. Therefore one need to consider majority of requirements during product development and technical data submission.
1. Administrative Documents
2. Chemistry, Manufacturing & Control documents
• API DMF Open part
• API Specification and Method of Analysis
3. Justification for Impurity Limits
• API and finished product impurity limits
• Pharmacopoeial limits (if any) or ICH limits
• API and finished product stability data
4. Manufacturing Formula & Process
• Manufacturing & packaging process
• Process validation protocol and report
5. Finished Product Specification and Method of Analysis
6. Batch Analysis
• Certificate of Analysis (COA)
8. Stability Data and Stability Protocol
9. Packing Material & Storage Condition
11. Pharmacological, Toxicological data
12. Registration fees
• Computation of batch size.
• Chromatograms during method validation for assay and impurities
• Justification for impurity limits
• Complete supporting data for process validation
• Cleaning validation report
• Residual solvent limit
• Reconstitution Stability (For oral suspensions)
• Preservative content and microbial limits
• Redispersibility and rheological properties
• Particle size distribution
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