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.
Classification of Pharma Market
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.
Registration Requirements for Rest of the World (ROW) Market
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 formula
• Manufacturing & packaging process
• Process validation protocol and report
5. Finished Product Specification and Method of Analysis
6. Batch Analysis
7. Excipients
• TSE/BSE certificates
• Certificate of Analysis (COA)
8. Stability Data and Stability Protocol
9. Packing Material & Storage Condition
10. Bioequivalence
11. Pharmacological, Toxicological data
12. Registration fees
Frequently Raised Queries by ROW Countries
• 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
• N-Nitrosamine declaration
• Reconstitution Stability (For oral suspensions)
• Preservative content and microbial limits
• Redispersibility and rheological properties
• Particle size distribution
