Pharmacy Courses

Regulatory Requirements of ROW Countries

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

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