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CAMS

7.01_Complementary_Medicines_ Quality_Safety_Efficacy_Dec13_v2_1.pdf

7.02_Roadmap_for_CAMs_Dec13_v1(PDF)

7.03_CAMs_Use of ZACTD format in preparation of registration application_Mar14_v2(PDF)

7.03_CAMs_Use of ZACTD format in preparation of registration application_Mar14_v2_showing_changes(PDF)

GG 38133 Vitamins and Minerals_Act_101-1965_20141028-Notice-R837(PDF)

Industry to comment

17.04_Fees for Complementary MedicinesNov13_v1(PDF)

2.06_Biostudies March 2014 v6_showing_changes(PDF)

2.07_Dissolution March 2014 v5_showing_changes(PDF)

2.35_Labelling_of_medicines_containing_sugars_Jun13_v1(PDF)

3.12_Veterinary_Orphan_Products_Aug11_v1(MSWord)

4.02_SA_Guide_to_GWP_v2_Mar12_for_comment (MSWord)

4.10_Guideline for export of medicines by Wholesalers_Nov14_v1_for_comment(PDF)

7.04_Quality Safety Efficacy_Health_Supplements_Nov14_v1(PDF)

8.01_General_Information – Medical Devices and IVDs_Aug14_v1_for_comment(PDF)

8.02_Medical_Device and IVDs Essential Principles_Aug14_v1_for_comment(PDF)

9.29_Applications for Registration of Pandemic Influenza Vaccines-Oct09_v1 (MS-Word 76kb)

9.34_Scheduling_matters_Jul10_v1 – Scheduling Matters (MS Word)

9.47_Multiple_applications_Jun13_v1.pdf

9.49_Scheduling of Meprobamate_Dec13_v1

Media Releases

10.04_Nevirapine Press Release 28/07/2003-Feb04_v1 (MS-Word 67kb)

10.07_Press Release for Rosiglitazone 05 July 2011_v1 (MS Word)

10.08_MCC_Press_statement_on_DPP_20111117

10.10 Media Release on registration of Complementary Medicines Jan14 v1.PDF

MCC no longer recommends the use of Monotherapy in preventing mother to child transimission of HIV (zipped Ms-Word 187kb)

MCC press statement on DPP

PICs_Press_Release_Paris_2014_v2(PDF)

PICs_Press_Release_Rome_2014(PDF)

Withdrawal of Vioxx (rofecoxib) from the South African Market (PDF 29kb)

Workshops and conferences

23.04_What are biotechnology products-Crommelin (zipped PDF 1548kb)

23.05_Immunogenicity of biopharmaceuticals – Schellekens et al (Zip 160kb)

23.06_Issues related to the formulation and delivery of pharmaceutical proteins – Crommelin (Zip 896kb)

23.07_Assessing Similarity of Biosimilars to Innovator Biopharmaceuticals II (Zip 573k)

23.08_Regulatory issues and drug product approval for biopharmaceuticals – shah (Zip 32kb)

23.09_Clinical trials for biotechnology medicines – Southern-JAS_v3 (Zip 20kb)

23.10_Regulatory testing of biological medicines – Vergeer (Zip 468kb)

23.11_Biotech 2007 Summary – Hela (zipped PDF 48kb)

23.12_Prerequisites for safe and efficacious biological medicinal products (Zip 338k)ƒ

9.50_CAMs_workshops between MCC and Industry_Dec13_v2.pdf

9.50_CAMs_workshops on registration_Dec13_v1

9.54_PDA_PICS_MCC_API_workshop_Jan14_v1(PDF)

Biologicals,Biosimilars: A South African Perspective of Registration – Mbelle (zipped PDF 79kb)

CAMs_Agenda_February_2014(PDF)

CAMs_workshop_Feb2014_Labelling_and_Advertising_of_CAMs(PDF)

CAMs_workshop_Feb2014_Licences_Complementary_Medicines(PDF)

CAMs_workshop_Feb2014_Prof_Eagles(PDF)

CAMs_workshop_Feb2014_PV_Complementary_Medicines(PDF)

CAMs_workshop_Feb2014_QSE_Dr_Adam(PDF)

CAMs_workshop_Feb2014_Registration_process_format_requirements(PDF)

CAMs_workshop_Feb2014_Roadmap(PDF)

CAMs_workshop_Feb2014_Vitamins_and_Probiotics_Dr_Neil_Gower(PDF)

CTD_to_eCTD(pdf)

eCTD_current_status_14-15_Feb2013(pdf)

eCTD_workshop_a_global_approach(pdf)

eCTD_workshop_Creating_an_eCTD_submission_supported_by_eCTDmanager(pdf)

eCTD_workshop_eCTD_readiness_of_Industry(pdf)

eCTD_workshop_EURS_is_Yours_as_reviewing_tool_at_MCC(pdf)

eCTD_workshop_MCC_Validation_criteria(pdf)

eCTD_workshop_Validation_of_Submission_on_Industry_and_Agency_side(pdf)

PICS_GMP_for_APIs_18_19March_2014(PDF)

SADC Harmonisation initiatives – ICH May 2007 (Ms-Powerpoint 77kb)

SARI_2014_1_BCS_and_Biowaiver_Dr_Vinod_Shah(PDF)

SARI_2014_1_Impact_PharmaSciences_on_Healthcare_Dr_Vinod_Shah(PDF)

SARI_2014_2_Challenges_faced_by_NRA_in_RSA_Prof_Eagles(PDF)

SARI_2014_3_Biowaiver_Prof_J_Dressman(PDF)

SARI_2014_Access_to_medicines_Stavros_Nicolaou(PDF)

SARI_2014_BCS_Biowaivers_JE_van_Oudtshoorn(PDF)

SARI_2014_Bioresponsive_vaginal_xerogel_Prof_GM_Pauletti(PDF)

SARI_2014_Biosimilar_Monoclonal_Antibodies_Dr_H_Leng(PDF)

SARI_2014_Complementary_medicine_challenge_Ms_M_Hela(PDF)

SARI_2014_Counterfeit_Medicines_Prof_J_Dressman(PDF)

SARI_2014_eCTD_ETaute(PDF)

SARI_2014_Exploiting_BDDCS_Dr_Leslie_Benet(PDF)

SARI_2014_GItract_Biorelevant_dissolution_media_Prof_Dressman(PDF)

SARI_2014_Impurities_and_Residues_Dr_A_Teasdale(PDF)

SARI_2014_Nanomedicine_Dr_Y_Lemmer(PDF)

SARI_2014_Plantbased_Materials_and_Preparations_Dr_D_Mancama(PDF)

SARI_2014_QA_Supply_Chain_WHO_Perspective_Dr_S_Kopp(PDF)

SARI_2014_Quality_of_APIs_Dr_JC_Gouws(PDF)

SARI_2014_Regulatory_Challenges_Topical_Formulations_Prof_GM_Pauletti(PDF)

SARI_2014_Transporters_Prof_D_Katerere(PDF)

ZA_Module_1_Specification(pdf)