L. Telisinghe, K. L. Fielding, J. L. Malden, et al.
1
Lamunu M, Lutwama J.J, Kamugisha J
1
Lesley Odendal
1
Lesotho National AIDS Commission, Government of Lesotho
1
Levenger, M., Ongeri, B., Wolde, A. & Kagoya, H.R.
1
Liberia Institute of Statistics and Geo-Information Services (LISGIS), Ministry of Health and Social Welfare, National AIDS Control Program, Liberia and ICF International
1
Liberty O. Yaneza, Ma. Consolacion Dolor-Torres, Sue Ann R. Locnen
1
Lindsay, Daniel et al.
1
Loulou Kobeissi
1
Luzi, S
1
M. A. Gasper, A. C. Hesseling, I. Mohar, et al.
1
M. Bray, M.S.Hirsch, D.Mitty, et al.
1
M. Danilovits
1
M. Dara, C. D. Acosta, V. Rusovich, et al.
1
M. Dara, M. Grzemska, M. E. Kimerling, et al.
1
M. Dara, O. Gozalov, O. Javadli, et al.
1
M. Doara, D. Choroliani, P. de Colombani
1
M. G. Whitfield, H. M. Soeters, R. M. Warren, et al.
1
M. Janier, V. Hegyi, N. Dupin et al
1
M. Smelyanskaya, C. Daniels, et al.
1
M. Smelyanskaya, J. Duncan (The Focus Group Consulting)
1
M. Thorogood
1
M. van den Boom
1
M. van der Boom, S. Talevski
1
M. Wolny, P. Kubaszewski
1
M.J. Choi
1
MacQuarrie, Kerry L.D., Sarah E.K. Bradley, Alison Gemmill, and Sarah Staveteig
1
Maddy Marasciulo-Rice
1
Madhukar Pai
1
Magdy Martínez-Solimán
1
Maina T., Kirigia D.
1
Maitland, K.
1
Malaria Consortium and Comic Relief
1
Malgosia Grzemska, Elizabeth Mathai
1
Malich, G
1
Malteser International
1
Manolito L. Chua, Marissa M. Alejandria
1
Mapako, Tonderai, Simbarashe Rusakaniko, Maarten J. Postma, Marinus van Hulst, Janet Dzangare, Stellah Ngwende, John Mandisarisa, Ponesai Nyika, David A. Mvere, Owen Mugurungi, and Mufuta Tshimanga
1
Marie Theres Benner and K. Peter Schmitz
1
Mark Newton Stella A. Eguma Olamide O. Dairo
1
Maroufou Jules Alao, Blaise Ayivi and Didier Lacombe
1
Martin Kayitale Mbonye, Sarah M Burnett, Robert Colebunders, et al.
1
Mary Kay Kindhauser, Tomas Allen, Veronika Frank, et al.
1
Mary-Anne Hartley, Alyssa Young, Anh-Minh Tran et al.
1
Masa
1
Maternal & Childhealth Advocacy International (MCAI) , Advanced Life Support Group (ALSG)
1
Maternal Health Division Department of Family Welfare Government of India
1
Mathieu Maheu-Giroux, Lawrence Joseph, Patrick Belisle and others
1
Mburu, Gitau
1
Medical Peace Work
1
Medicines Control Authority of Zimbabwe (MCAZ) | Ministry of Health and Child Care
1
Medicines Control Council (MCC), Department of Health Republic of South Africa
1
Megan S. Towle, et al.
1
Meierhofer, R
1
Mekonen, T.T.
1
MHO
1
Minister of Health & Social Welfare (MoHSW), Kingdom of Lesotho
1
Ministère de la Santé Publique, République Démocratique du Congo
1
Ministry of Law and Justice (Legislative Department), India
1
Ministry of Healt
1
Ministry of Health & Family Welfare Government of India
1
Ministry of Health & Ministry of Local Government, Gabarone, Botswana
1
Ministry of Health & Sanitation, Sierra Leone
1
Ministry of Health (MoH), Malawi and ICF International
1
Ministry of Health and Child Welfare
1
Ministry of Health and Child Welfare,Zimbabwe
1
Ministry of Health and Ethiopian Health and Nutrition Research Institute, Federal Democratic Republic of Ethiopia
1
Ministry of Health and Family Welfare & Indian Council of Medical Research
1
Ministry of Health and Family Welfare Nirman Bhawan New Delhi
1
Ministry of Health and Family Welfare, Directorate-General of Health Services, Mycobacterial Disease Control, National Tuberculosis Control Programme
1
Ministry of Health and Family Welfare, Government of India
1
Ministry of Health and Population in Haiti
1
Ministry of Health and Sanitation Sierra Leone,
1
Ministry of Health and Sanitation, Sierra Leone
1
Ministry of Health and social affairs of Georgia
1
Ministry of Health and Social Services (MOHSS), UNAIDS
1
Ministry of Health and Social Welfare (MOHSS)
1
Ministry of Health and Social Welfare (MOHSW) and ICF Macro
1
Ministry of Health and Social Welfare (MoHSW), Kingdom of Lesotho
1
Ministry of Health and Social Welfare, India
1
Ministry of Health and Social Welfare, Central TB Division, India
1
Ministry of Health and Social Welfare, Dar es Salaam, Ministry of Health, Zanzibar, National Bureau of Statistics, Zanzibar, Tanzania, and ICF International
1
Ministry of Health DR Congo
1
Ministry of Health Kenya
1
Ministry of Health Malawi
1
Ministry of Health Republic South Sudan
1
Ministry of Health Rwanda, Biomedical Center Institute of HIV
1
Ministry of Health Saudi Arabia
1
Ministry of Health Uganda, Control of Diarrheal Diseases
1
Ministry of Health, Botswana
1
Ministry of Health, Cambodia
1
Ministry of Health, Demographic Republic of the Congo
1
Ministry of Health, Ethiopia
1
Ministry of Health, Gabarone, Botswana
1
Ministry of Health, Ghana, World Health Organizaiotn (WHO) and Ghana Health Service
1
Ministry of Health, Government of Lesotho
1
Ministry of Health, Government of Liberia
1
Ministry of Health, Government of Nepal
1
Ministry of Health, Guinea
1
Ministry of Health, Liberia
1
Ministry of Health, Liberia, World Health Organization (WHO), and Centers for Disease Control and Prevention (CDC)
1
Ministry of Health, National Malaria Control Programme
1
Ministry of Health, Republic of Botswana
1
Ministry of Health, Republic of Kenya
1
Ministry of Health, Republic of Uganda | NtlP
1
Ministry of Health, South Africa
1
Ministry of Health, Swaziland
1
Ministry of Heatlh and Social Welfare, Tanzania
1
Ministry of Public Health and Sanitation, Kenya
1
Ministry of Public Health and Sanitation, Ministry of Medical Services
1
Ministry of Public Health& Sanitation. Ministry of Medical Services. Kenya
1
Ministry of Public Health, Quatar
1
Ministry of State for Special Programmes (MSSP) and Ministry of Provincial Administration and Internal Security - National Disaster Operation Centre (NDOC), Kenya
1
Moe Aung
1
MOHS Sierra Leone, World Health Organization (WHO)
1
Morbidity and Mortality Weekly Report
1
MSF
1
Muga R., Ndavi P., Kizito P. et al.
1
Myanmar Red Cross Society
1
N. Gebreselassie , C. Lienhardt, L. Anderson et al.
1
N. Ait-Khaled, D. Enarson
1
N. Schoenfeld, W. Haas, E. Richter, et al.
1
N.Nortey Hanson-Nortey
1
NACO, DOTS
1
National Center for Tuberculosis and Leprosy Control, Cambodia
1
National Malaria Control Programme (NMCP) Sierra Leone, Statistics Sierra Leone, University of Sierra Leone, et al.
1
National Academies of Sciences, Engineering, and Medicine
1
National Academy of Medical Sciences
1
National Agency for Control of AIDS (NACA)
1
National Agency for the Control of AIDS (NACA)
1
National Agency for the Control of AIDS (NACA), Abuja Nigeria
1
National AIDS and STIs Control programme (NASCP), Federal Ministry of Health, Nigeria
1
National AIDS Commission of Liberia
1
National AIDS Commission, Ministry of People's Welfare Republic of Indonesia
1
National AIDS Control Organisation
1
National AIDS Control Organisation (NACO), Government of India
1
National AIDS Control Organisation, Ministry of Health & Family Welfare , Government of India,
1
National AIDS Control Organisation, Ministry of Health &
1
National AIDS Control Organization (NACO)
1
National AIDS Control Program
1
National AIDS Secretariat Sierra Leone, et al.
1
National AIDS&STI Control Program Kenya
1
National Blood Transfusion Council (NBTC)
1
National Bureau of Statistics (NBS)
1
National Cancer Control Programme, India
1
National Center for AIDS and STD Control
1
National Center for AIDS and STD Control (NCASC)
1
National Center for Disease Prevention and Control Department of Health, Philippines
1
National Center for Emerging and Zoonotic Infectios Diseases
1
National Center for TB and Leprosy Control, Cambodia
1
National Center for Tuberc ulosis and Leprosy Control (CENAT) , Cambodia
1
National Center for Tuberculosis and Leprosy Control (CENAT)
1
National Center for Tuberculosis and Leprosy Control (CENAT), Cambodia
1
National Center for Tuberculosis and Leprosy Control, Cambodia
1
National Centre for AIDS and STD Control
1
National Centre for AIDS and STD Control (NCASC) Nepal
1
National Clinical Guideline Centre
1
National Council for Law Reporting with the Authority of the Attorney-General
1
National Department of Health, South Africa
1
National Dept. of Health, South Africa
1
National Drug Authority (NDA), Uganda
1
National Epidemiology Center Department of Health Philippines
1
National Health Mission (NHM), Ministry of Health & Family Welfare, Government of India
1
National HIVAIDS Council Zambia
1
National Institue of communicable Diseases, India
1
National Institute of Disaster Management (India)
1
National Institute of Health
1
NATIONAL INSTITUTE OF MALARIA RESEARCH NEW DELHI
1
National Leprosy and Tuberculosis Control Program (NLTCP)
1
National Leprosy Eradication Programme
1
National Malaria Control Programme (NMCP) Communicable Disease Control Division Directorate General of Health Services Ministry of Health & Family Welfare Bangladesh
1
National Malaria Control Program (NMCP) [Liberia], Ministry of Health (MOH), Liberia Institute of Statistics and Geo-Information Services (LISGIS), and ICF
1
National Malaria Elimination Centre, Ministry of Health, Zambia
1
National Malaria Elimination Programme Federal Ministry of Health National Population Commission, National Bureau of Statistics Federal Republic of Nigeria , et al.
1
National Polio Emergency Operations Centre (EOC), Islamabad, Pakistan
1
National Primary Health Care Development Agency, Abuja, Nigeria
1
National Public Health Institute of Liberia (NPHIL)
1
National Rural Health Mission, DOTS
1
National Rural Health Mission, NACO
1
National Social Mobilisation Pillar
1
National Statistical Office Zomba, Malawi
1
National Statistical Office (NSO) and ICF Macro
1
National Statistical Office Zomba, Malawi
1
National TB
1
National TB Control Programme (NTP), DGHS, MoHFW
1
National Tubercolis and Leprosy Control Programme, Federal Ministry of Health, Nigeria
1
National Tuberculosis and Leprosy Programme Ministry of Health and Social Welfare, Tanzania
1
National Tuberculosis Leprosy and Lung Disease Program (NTLD-program), Ministry of Health, Republic of Kenya
1
National Vector Borne Disease Control Programme, Government of India
1
NCDC
1
Nepal, Ministry of Health, National Centre for AIDS and STD Control
1
Net Hope
1
Neuron Review
1
Nicholson, S., Clarke, A.
1
Nigeria Center for Disease Control, Federal Ministry of Health, Abuja
1
Nigeria Centre for Disease Control (NCDC)
1
Nigeria Centre for Disease Control (NCDC) Government of Nigeria
1
Nigeria Centre for Disease Control, Abuja, Nigeria
1
NIOSH
1
Noel G. Macalalad, Ma. Cecilia G. Ama, Arthur B. Lagos et al.
1
Noormahomed E, et al.
1
Novartis Comprehensive Leprosy Care Association
1
Nutrition Cluster
1
Nwe Ni Myint et al.
1
Odugleh-Kolev, A.
1
ohns Hopkins Center for Communication Programs
1
Omowunmi Aibana , Andrej Slavuckij , Mariya Bachmaha, et al.
1
Ophthalmic Services Unit and the Division of Non Communicable Disease (DNCD), Ministry of Health Kenya
1
Organisation for the Prohibition of Chemical Weapons (OPCW)
1
Organización Panamericana de la Salud
1
OSHA
1
Overseas Development Institute
1
Oxfam
1
P. de Colombani
1
P. de Colombani, S. Ahmedov, K. Blondal, et al.
1
P. de Colombani, V. Hollo, N. Jansen, et al.
1
P. Glaziou, C.Sismanidis, P. J. Dodd, et al.
1
P. Zucs, et al.
1
Pan American Health Association (PAHO)
1
Pan American Health Organisation PAHO
1
Pan American Health Organization (PAHO)
1
Pan American Journal of Public Health
1
Panel on Antiretroviral Guidelines for Adults and Adolescents
1
Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children
1
Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents
1
Parliament of Lesotho
1
Partners in Health, World Health Organization
1
PATH
1
Pathfinder International
1
Paul Roddy, Natasha Howard, Maria D. Van Kerkhove, et al.
1
Pedro Alonso, Kevin Baird, David Brandling-Bennett et al.
1
PEPFAR
1
Pharmacy, Medicines & Poisons Board, Malawi
1
Pharmacy, Medicines and Poisons Board, Malawi
1
Philippine Heart Association
1
Philippine Society for Microbiology and Infectious Diseases, Philippine College of Chest Physicians, Philippine Academy of Family Physicians
1
Plan
1
Polrat Wilairatana, Srivicha Krudsood, Ma. Sandra B. Tempongko et al.
1
Portaels, F-
1
President's Malaria Initiative
1
President's Malaria Initiative et al.
1
Prof. C. Abobltins, L. Brown, Prof N. Curtis, et al.
1
Prof. G. N. Lule, Dr. B. Nyawira
1
r Internationale Zusammenarbeit (GIZ) GmbH ;
1
R. Colebunders
1
R. Coninx
1
R. G. Thomas-Reilly, F. Tozija, V. Soltan
1
R.Beaglehole, and T. Kjellström
1
Radcliffe
1
Rajesh Upadhyay, Milind Y Nadkar, A Muruganathan
1
REACT Cameroun
1
Regional Office Africa
1
Republic of Kenya, Ministry of Health
1
Republic of Libera, Ministry for Health and Social Welfare
1
Republic of Liberia
1
Republic of Senegal , Ministry of Public Health and Prevention, Department of Medical Prevention
1
Republic of the Gambia, Ministry of Health and Social Welfare, National Leprosy
1
Research Institute for Tropical Medicine National Tuberculosis Reference Laboratory
1
Research Triangle Institute (RTI) International
1
Rockville, Maryland, USA: ICF International
1
Rontgene M. Solante, Manolito L. Chua
1
Royal Government of Cambodia
1
Rupérez et al.
1
Rwanda Biomedical Centre, Institute of HIV
1
S. Ali, A. Haileamlak, A. Wieser, et al.
1
S. Bahendeka, S.Colagiuri, S. Mendis, et al.
1
S. Colt, M.N. Garcia-Casal, J.P. Peña-Rosas, et al.
1
S. Meek, M. Rowland, and M. Connolly
1
S. Oza, A.A. Sesay, N.J. Russel, et al.
1
SAARC TB and HIV
1
Safeguarding Health in Conflict Coalition
1
Safrani, N.
1
Salmon, S.
1
Salvage J, Rowson M, Melf K, Wilmen A
1
Salvatore Noto, Pieter A. Schreuder and Bernard Naafs
1
Sameh Saleeb, Seydou Doumbia
1
Samuels, F., Amaya, A.B., Rodríguez Pose, R. and Balabanova, D.
1
Sandrine Martin
1
Santesso, N.
1
Saranya A, Selvaraj E Lee, Mason Harrell, et al.
1
Schieffelin, JS.
1
Schwienhorst, E.M.
1
SCMS | PEPFAR
1
Seung Hee Lee-Kwan, et al.
1
Sexual Health and Blood Borne Virus Unit Centre for Disease Control
1
Sharifa Begum, et al.
1
Sharing and Learning from Country Experiences
1
Shears, Paul, T.J.D. O'Dempsey
1
Sheikh, Nurnabi
1
Shemsedin Toyba et al.
1
Sierra Leone Government, National HIV and AIDS Secretariat
1
SIERRA LEONE NURSES ASSOCIATION
1
Silvia Dallatomasina, et al.
1
SMAC
1
Social Science in Humanitarian Action: A Communication for Development Platform
1
SODIS, Antenna Water
1
Soka, M.J.
1
Solidarités International
1
Spotlight NSP
1
State Goverment Victoria
1
Statistics Sierra Leone, Ministry of Health and Sanitation Sierra Leone, ICF International
1
Stefan Mauss, et al.
1
Stephen Graham, Malgosia Grzemska, Suzanne Hill et al
1
Stephen M. Graham
1
Stephen N. Wong, Jane R. Campos, Ian Homer Y. Cua et al.
1
Stockholm Drug and Therapeutics Committee
1
Stop TB Department
1
Stop TB Partnership to reach
1
Stop TB Partnership. Working Group on TB
1
Strengthening Pharmaceutical Systems
1
Strengthening Pharmaceutical Systems (SPS) Program
1
Sultana, Marufa et al.
1
Superior Health Council
1
Suter, F
1
Swaziland Paediatric HIV G uidelines 2010 Ministry of Health and Social Welfare
1
Syrian American Medical Society
1
T. Colton
1
T. Hiatta and N. Nishikior
1
T. Jaenisch, K.D. Rosenberger, C. Brito, et al
1
T. Jones and J. Bedford
1
Tambo, Ernest
1
Tanzania Commission for AIDS (TACAIDS)
1
Tanzania Diabetes Association
1
Tanzania Food and Nutrition Centre
1
TB Care II
1
TB/CTA
1
TDR
1
The African Child Policy Forum (ACPF)
1
The Audit Service Sierra Leone
1
The Cameroon Academy of Sciences
1
The Center for Health Market Innovations.
1
The DHS Program
1
The European Respiratory Journal
1
The fight against fake drugs by NAFDAC in Nigeria Olike Chinwendu
1
THE GOVERNMENT OF THE KINGDOM OF SWAZILAND MINISTRY OF HEALTH AND SOCIAL WELFARE
1
The International Center for AIDS Programm
1
The Johns Hopkins and the International Federation of Red Cross and Red Crescent Societies
1
The Johns Hopkins Center for Humanitarian Healt
1
The National Tuberculosis and Leprosy Programme, Zambia
1
The Polio Global Eradication Initiative
1
The Republic of the Union of Myanmar, Ministry of Health and Sports, Department of Health
1
The Republic of the Union of Myanmar, Ministry of Health, Department of Health, Child Health Division
1
The Republic of the Union of Myanmar, Ministry of Health, Department of Health, National AIDS Programme
1
The Republic of the Union of Myanmar, Ministry of Health, Department of Health, National Tuberculosis Programme
1
The Republic of the Union of Myanmar, Ministry of Health, Department of Public Health
1
The Sentinel Project
1
The William J. Clinton Foundation
1
Thomas Joseph, Nathalie Likhite, Lana Syed et al.
1
Tobler, M
1
Travis Yates, Jelena V. Allen, Myriam Leandre Joseph et al.
1
Treat All
1
Treatment Action Group
1
Trials
1
Tuberculosis Coalition for Technical Assistance (TBCTA), USAID
1
U.S Department of health and human service
1
U.S. Agency for International Development (USAID)
1
U.S. Department of Health and Human Services. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases
1
U.S. Department of Human Services
1
U.S. President’s Malaria Initiative (PMI), CDC, USAID, et al.
1
UN Development Group
1
UN Development Programme
1
UN Development Programme, UN Mission for Ebola Emergency Response
1
UN High Commissioner for Refugees, Protection Cluster, Health Cluster
1
Un Security Council
1
UNAIDS | GAMET
1
UNAIDS, The National AIDS Authority (NAA)
1
UNAIDS, UNICEF
1
UNIECF
1
UNION
1
UNITE FOR DIABETES PHILIPPINES
1
United Nations Children’s Fund (UNICEF)
1
United Nations Children’s Fund (UNICEF), Global Alliance for Improved Nutrition (GAIN)
1
United Nations Economic Commission for Africa
1
United Nations, The World Bank, European Union and African Development Bank
1
United States Agency for International Development (USAID), SIAPS
1
United States Government Zambia Interagency Team
1
University of Oslo
1
University of Sheffield
1
University of Zambia
1
Uppsala Monitoring Centre
1
US Agency for International Development
1
US Agency for International Development, Centers for Disease Control and Prevention
1
US Department of Homeland Security, US Department of Health and Human Services
1
US Embassy Freetown
1
USAID, SPS, Strengthening Pharmaceutical Systems Program-Kenya
1
USAID, CapacityPlus & PEPFAR
1
USAID, et al.
1
USAID, l'Union, Initiative 5%
1
USAID, PEPFAR, Health Policy Project
1
V. Allread
1
V. Nankabirwa , J. K. Tumwine, O. Namugga, et al.
1
Velho Barreto de Araújo, T.
1
Vitillo, B.
1
Voluntary Service Overseas
1
Walker, N.F.
1
Wang, S., N. Hoohlo, I. Tshabalala, K. Ntoi, and T. Sepetla
1
Wardlaw, Tessa M.
1
WASH Cluster
1
Western Pacific Region
1
WHO Regional Office for Europe (WHO
1
WHO Collaborating Centre for community participation in palliative care and long term care
1
WHO SEARO/Department of Control of Neglected Tropical Diseases
1
WHO South East Asia Regional Office
1
WHO South Sudan
1
WHO South-East Asia New Delhi
1
WHO, HHS-CDC, GAP
1
WHO, UNFPA, UNICEF, World Bank Group
1
WHO, Unicef
1
WHO=
1
Wiedenmayer, K. et al.
1
Word Health Organization
1
Word Health Organization/ Regional Office of South-East Asia
1
World Alliance for Patient Safety
1
World Bank
1
World Health Organisation (WHO) Country Office for Nepal
1
World Health Organisation (WHO), USAID, The Global Fund, et al.
1
World Health Organisation Zimbabwe
1
World Health Organisation, International Labour Organization
1
World Health Organization (WHO), International Pharmaceutical Federation (FIP)
1
World Health Organization (WHO), International Water Association (IWA)
1
World Health Organization (WHO), Kenya Country Office
1
World Health Organization (WHO), Ministry of Health, DR Congo
1
World Health Organization (WHO), Regional Office for Africa
1
World Health Organization (WHO), Regional Office for South-East Asia
1
World Health Organization et al.
1
World Health Organization South Sudan, Ministry of Health Republic of South Sudan
1
World Health Organization WHO, Bangladesh
1
World Health Organization WHO, Regional Office for Europe
1
World Health Organization WHO, Regional Office for Western Pacific
1
World Health Organization WHO, Regional Office of Africa
1
World Health Organization WHO, Regional Office of Europe
1
World Health Organization WHO, SEARO
1
World Health Organization WHO, Stop TB
1
World Health Organization, Stop TB Partnership
1
World Health Organization, et al.
1
World Health Organization, Health Cluster
1
World Health Organization, Pan American Health Organization
1
World Health Organization, Regional Office Africa
1
World Health Organization, Regional Office for Africa. Ministry of Health, Botswana
1
World Health Organization, Regional Office for Europe
1
World Health Organization, Regional Office South-East Asia
1
World Health Organization, UN Children's Fund
1
World Health Organization, UN Office for the Coordination of Humanitarian Affairs, UN Mission for Ebola Emergency Response
1
World Health Organization, UNAIDS, United Nations Office on Drugs and Crime
1
World Health Organization, UNICEF, United Nations Population Fund
1
World Health Organization, WASH Cluster, Health Cluster
1
World Health Organization, Western Pacific
1
World Health Organization, Western Pacific Office
1
World Health Organization, Western Pacific Region
1
World Health Organization,et al.
1
World Health Organization. Regional Office for South-East Asia
1
World Vision
1
WPSAR
1
Yawalker, S.
1
Z. Diaz-Bello, C. Colmenares, et al.
1
Zanzibar AIDS Commission (ZAC)
1
Zimbabwe National Statistics Agency (Z IMSTAT) and ICF International. 20
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.