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  • 1.  Submission Requirements for African Countries

    Posted 09-Dec-2013 22:50
    Hello,
    I am seeking information on basic regulatory submission requirements for drug products for Northwest and South African countries. For example, what are the requirements in these countries regarding CTD, electronic versus paper copy, allowable languages, submission mailing addresses, etc.? Can anyone recommend any sources (preferably in English) where this information can be found?
    Thank you in advance for any assistance you can provide.

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    Jill Sackett
    Director
    Libertyville IL
    United States
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  • 2.  RE:Submission Requirements for African Countries

    Posted 10-Dec-2013 03:36

    Hi ,

    If you provide your email id then I can send you PPT and other guidances for your quick reference. My email id is rajashrio@gmail.com.

    You may also browse through MCC guidelines on their HA website along with below links. http://www.kznhealth.gov.za/research/mccinfo.pdf
    http://www.pharmaguideline.com/2010/10/mcc.html
    http://www.doh.gov.za/show.php?id=2863

    Just to share my own experience;--
    Earlier we used to submit dossiers to MCC in MRF-1 format (i.e. Part I, IA, IB, IC, ID and Part II, Part III, Part IV, Part V) whereas from 2010 onwards we have started submitting dossiers in CTD format(Module-1,2,3,4,5).

    The language used is English(British)

    Thanks and let me know if you need more information.

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    RAJASHRI OJHA PHD
    COGNIZANT TECHNOLOGY SOLUTIONS
    THANE
    India
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    Original Message


  • 3.  RE:Submission Requirements for African Countries

    Posted 11-Dec-2013 11:44
    Dear Jill and Colleagues:

    I agree with our colleagues' feedback.  

    For South Africa, a CPP will be required and it will have to be legalized and authenticated by the SA Consulate in the country of issuance.  Consider providing a streamlined version of the CTD (filed in the US or EU) so that you are better able to manage post-approval changes without having to file post-approval filings as the review and approval process in South Africa is lengthy.  Electronic submissions are not required.  In my past experience, a streamlined submission, with the pertinent information, is preferable.  You will need to have a responsible person (preferably a pharmacist) in-country to act as you legal representative.  

    For Northwest Africa, I propose you consider filing and even more abbreviated filing, also to help manage post-approval changes.  You may need to inquire in your product needs to be on the country's list of Essential Medicines as the precursor to your submitting your application.  Using the country's application forms and payment of fees in the local currency, as required is the best way to go.  You may need someone to help you navigate the review process so that attention is given to you application once filed.  

    If you have a specific list of countries in which you are looking to file in, I may be able to provide you with more details.  If you are able to get your product WHO Prequalified, most will put a lot of weigth on that.  Link:  http://apps.who.int/prequal/

    Hope this helps.  Good luck.

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    Carla Fiankan
    Vice President
    Intermune
    Brisbane CA
    United States
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    Original Message


  • 4.  RE:Submission Requirements for African Countries

    Posted 10-Dec-2013 08:46
    You may need a CPP for South Africa.  Even for a much needed low cost Aids drug, we needed a CPP first, then approval from South Africa. 

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    Jim Bonner PHD
    The One When
    Skippack PA
    United States
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    Original Message


  • 5.  RE:Submission Requirements for African Countries

    Posted 10-Dec-2013 10:41
    Dear Jill,

    For South Africa you can find out about CTD requirements on the MCC website http://www.mccza.com/, under "guidelines and forms". Though MCC informs about eCTD, according to my local partner there, it is still the paper form which is common. As for the language, it is English for the dossier, and a second National Language for the labelling is required (e.g. Afrikaans). Should you need assistance in this, don't hesitate to contact me on cornelia@camara-partners.com.

    with best regards,

    Cornelia

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    Cornelia CAMARA
    Expert Partner and Managing Director
    Camara and Partners
    Nyon
    Switzerland
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    Original Message


  • 6.  RE:Submission Requirements for African Countries

    Posted 10-Dec-2013 13:05
    Hi Jill,

    Someone (I'm sorry I don't remember who!) shared a link a few months ago to a website for the Global Health Technologies Coalition. It has summary regulatory information for a variety of countries, including several in Africa. It might have some useful information for you. http://regulatory.ghtcoalition.org./

    Jennifer

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    Jennifer Cabralda, RAC
    Neovasc Inc.
    Richmond BC
    Canada
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    Original Message


  • 7.  RE:Submission Requirements for African Countries

    Posted 11-Dec-2013 05:15
    Hi Jill,

    For most of the African countries, dossiers has to be submitted via paper copy in CTD format or country specific format with less data. CPP, Anglo french artworks (West African countries), 3 batches Zone IV b stability data of at least 12 months at the time of submission, samples are the basic requirements of an African country dossier.
    Manufacturing facility has to be audited by regulatory authorities in case of Kenya, Zimbabwe, Tanzania & Nigeria submissions. 
    Hope this information will be useful to you.  

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    Srinivasa Rao Moturi
    Regulatory affairs manager
    Silom Medical International Co.,Ltd
    Bangkok
    Thailand
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    Original Message


  • 8.  RE:Submission Requirements for African Countries

    Posted 12-Dec-2013 03:47
    Hi Jill,

    The following web site contains regulatory information of several African countries which may be helpful.
    http://regulatory.ghtcoalition.org./

    Best regards,

    Toru


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    Toru Murakumo RAC
    Group Manager
    Mitsubishi Tanabe Pharma Corporation
    Tokyo
    Japan
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    Original Message