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Idrees Mbenga

Deepthi Ravulaparthi

Suren Dheenadayalan

Srini Sadhu

Alexander Samorodov

Muddassir Mohammed

Robert Macdougall

Claudia Fields

Raghu Swaminathan

Rajiv Rangan

Jince Varghese

Situn Mahapatra

Rahul Kumar

Rakesh Kambham

Uma Reddy

Sowjanya Bandi

Anusha Sundaram

Praveen Kumar

Warren Strauber

Sandesh Tetgure

Ashima Bansal Gupta

Aarthi Omprakash

Sangya Shaily

Dinesh Kotapally

Sibtain Farooq

Antra Raina

Tamal Dasgupta

Niveda Ramkumar

Atul Kumar Yadav

Sowbhagya Neti

Chaitanya Ingle

Sunitha Anumula

Keerti Kuchipudi

Wayne Howell

Hemanth Reddy

Steven Williams

Hershita Singh

Annie Merlyn Masih

Sagar Devunoori

Prasanna N G

Sakshi G.

Sivaram Manavarthi

Purvanshi Singh

Satish Chandra Behara

Sitaram Bhandaram

Chittineedi Manideep

Kranthi Reddy

Reshu Pandey

Megha Tiwari

Yendala Shravani

Deepak Kavathe

Pratik Japee

Sakshi Bajpai

Sudheer Goparaju

Shoukatali Shaik

Shiva D

Vivek Pokhare

Ashlesh Bodugam

Mohammed Jahangir

Ramesh Thamvada

Abhinay Kondepudi

Ester Brown

Vishal Sony

Ambrish Pratap Singh

Srikanth Simhadri

Ravi Kankanala

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CTD Conversion
In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.
From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).
Freyr is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate.  For some of these global companies CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.
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Good Manufacturing Practice
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.
Regular periodic or rolling quality reviews of all registered medicinal products, including export only products are conducted.
The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken.
Medicines Control Council?s (MCC)  general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP).
Under Section 22C of the Act, all South African manufacturers should be licensed
The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers
When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved
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Medicines Registration
Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council?s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 and the Regulations and Guidelines published in terms thereof.
A written notification from the Minister to the effect that the medicine is considered essential to national health; an expert report (which is not more than 2 (two) years old; a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application.
The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application.
The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.
Applications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country.
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This article talks about an overview on Therapeutic Products? Regulation in New Zealand.