HIV/AIDS Programme USER GUIDE DRUG REGULATORY STATUS DATABASE (DRS) Version 2

HIV/AIDS Programme USER GUIDE DRUG REGULATORY STATUS DATABASE (DRS) Version 2 November 2012

HIV/AIDS Programme USER GUIDE DRUG REGULATORY STATUS DATABASE (DRS) Version 2 November 2012

WHO Library Cataloguing-in-Publication Data: User guide: Drug Regulatory Status Database (DRS) version 2. 1.Drug and narcotic control. 2.Essential drugs. 3.HIV infections drug therapy. 4.Anti-Retroviral agents supply and distribution 5.Handbooks. 6.Databases, Pharmaceutical. I.World Health Organization. ISBN 978 92 4 150505 5 (NLM classification: WC 503.2) World Health Organization 2013 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press through the WHO web site (www.who.int/ about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Layout by Genève Design

CONTENTS 1. Introduction................................. 2 1.1 Objective.................................... 2 1.2 Mandate.................................... 2 1.3 Funding..................................... 2 1.4 DRS Access.................................. 2 2. Terminology................................ 3 3. DRS Data.................................. 4 3.1 Data Source.................................. 4 3.2 Data Entry and Verification........................... 4 3.3 Quality Assurance............................... 4 3.4 Procedures................................... 4 3.5 Caveats..................................... 4 4. Product Categories............................. 5 4.1 Antiretroviral drugs (ARVs)........................... 5 4.2 TB medicines.................................. 5 4.3 Artemisinin-based combination therapies (ACTs)............... 5 5. Reports................................... 6 5.1 Types of reports................................ 6 5.2 Accessing reports............................... 6 6. Frequently Asked Questions....................... 15 6.1 How often is the DSR data updated?.................... 15 6.2 What is the added value of the DRS?.................... 15 6.3 Does the DRSD include pharmaceutical products used in the private sector market?............................ 15 6.4 Can the DRS be expanded to include all essential medicines?....... 15 6.5 Why is the pharmaceutical product registration period not specified in the DRS?............................. 15 7. Communication/Visibility......................... 16 7.1 Quarterly report................................ 16 7.2 Feedback................................... 16 1

1. INTRODUCTION 1.1 Objective The Drug Regulatory Status Database (DRS) was initially established in 2008 by the AIDS Medicines and Diagnostics Service (AMDS) of the World Health Organization (WHO) HIV Department, and updated in 2012. AMDS is a network of technical partners providing support and guidance to countries regarding their procurement and supply management of HIV commodities. The WHO HIV Department hosts the AMDS secretariat, and represents WHO in the partnership. The DRS is a database of the registration status of antiretroviral drugs in low, lower middle and upper middle income countries. 1 The DRS focuses only on ARVs which have been approved through the WHO prequalification programme or have been approved through a stringent regulatory process. The rationale behind its creation was to assist countries with procurement and supply chain management decisions, by providing actual drug registration status in countries, which would ultimately expedite in-country delivery of drugs. 1.2 Mandate Since its creation in 2008, the DRS has focused on monitoring the registration and marketability of ARVs in low/lower-middle/upper-middle income countries. In 2011, its scope was extended to cover tuberculosis (TB) medicines. However, the TB data will only be available in the public domain during the first quarter 2013. 1.3 Funding To date, the project has been funded by WHO and the Bill and Melinda Gates Foundation. 1.4 DRS Access The DRS is available online at: http://apps.who.int/hiv/amds/patents_registration/drs/ and currently includes only ARV registration information. It is recommended that you read and familiarize yourself with this User Guide before you access the DRS. 1 The classification of countries is done using the World Bank Atlas classification method and is based on Gross National Income per capita. 2

2. TERMINOLOGY Brand Name: Proprietary name or trademark and identifies one particular drug from one seller. One drug can be sold under several brand names Country of manufacture: Country in which a pharmaceutical product has been produced by the manufacturer. Dosage form: The physical type and amount of a medication and includes capsules, tablets, injections, liquids, creams and suppositories. GFQA Standard: The Global Fund Quality Assurance standard (ARVs and TB medicines which have been approved through the WHO prequalification programme or have been approved through a stringent regulatory process) International Nonproprietary Names (INN): Identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name Manufacturer: A company that produces, packages, repackages, labels and/or relabels pharmaceutical products. Manufacturing site: The site where the pharmaceutical product was manufactured. Pharmaceutical product: Any substance or combination of substances marketed or manufactured to be marketed for treating or preventing disease in human beings, or with a view to making a medical diagnosis in human beings, or to restoring, correcting or modifying physiological functions in human beings. Prequalification: WHO standardized quality assessment procedure to evaluate the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies. Quality standards: The benchmark to ensure that products and services are safe. Status: The registration status of a specific pharmaceutical product. Strength: The strength of the active ingredient contained in a pharmaceutical product. Stringent Regulatory Authority (SRA): An International Committee on Harmonisation (ICH) member country, an ICH observer or any country whose regulatory authority is associated with an ICH member through a legally binding mutual recognition agreement. Therapeutic category: Used to differentiate TB medicines from HIV drugs WHO Prequalification: Refers to the prequalification of medicines and means the process of ensuring that medicines for high burden diseases meet global standards of quality, safety and efficacy, in order to optimize the use of health resources and improve health outcomes. 2 2 Refer to http://www.who.int/topics/prequalification/en/ 3

3. DRS DATA 3.1 Data Source The DRS indicates the in-country registration status of pharmaceutical products, based on information voluntarily provided to WHO by manufacturers. The data is provided to WHO for the sole purpose of inclusion in the DRS. The data is not available for dissemination to 3rd parties other than via the DRS mechanism. 3.2 Data Entry and Verification There is no standard format for data entry and this ensures that the provision of data and database entry is a straightforward procedure. Data is sent to WHO periodically by Manufacturers. Thereafter, the data is uploaded into the DRS and screened by WHO to ensure that there are no duplications. This includes randomized requests by WHO to National Drug Regulatory Authorities in countries to verify the accuracy of registration data for their country. 3.3 Quality Assurance The DRS database only contains data pertinent to the registration status of pharmaceutical products which have either been approved through WHO prequalification or Stringent Regulatory Authority (SRA) approved. 3.4 Procedures The data is processed in three sequential steps which involve coding, validation by algorithms to detect different types of duplicates and determination of the registration status to be displayed in the database. Registration expiry date is treated as confidential information. 3.5 Caveats When interpreting the DRS data, the following caveats need to be borne in mind: Pharmaceutical product registration is a highly dynamic area and data can therefore never be 100% accurate or complete at any given point of time; The data is provided by manufacturers on a voluntary basis and WHO makes no representations or warranties, either expressed or implied, as to its accuracy, completeness or fitness for a particular purpose; WHO accepts no responsibility or liability with regard to the reliance on, or use of, such data and information. 4

4. PRODUCT CATEGORIES 4.1 Antiretroviral drugs (ARVs) The DRS provides pharmaceutical product registration status in respect of 40 adult ARV formulations and 35 paediatric formulations. 4.2 TB medicines By early 2013, the DRS will include the pharmaceutical product registration status of TB medicines for both 1st and 2nd line adult formulations, together with paediatric 1st line products. 4.3 Artemisinin-based combination therapies (ACTs) By mid-2013, the DRS will include the pharmaceutical product registration status of ACTs for both 1st and 2nd line adult formulations, together with paediatric 1st line products. 5

5. REPORTS 5.1 Types of reports For each record entered in the DRS, data is provided as to the INN, brand name, strength, dosage form, country, manufacturer, registration status and applicable quality standard. The DRS reports have been fully automated and are simple to generate according to the information required by the user. 5.2 Accessing reports Step 1: Connect to the DRS - http://apps.who.int/hiv/amds/patents_registration/drs/ 6

Step 2: Take note of the 7 boxes which appear initially upon opening the link as per the screen shot below: Therapeutic category INN Strength Dosage Form Country you can select multiple countries by pressing the CONTROL key simultaneously with selecting the countries you wish to generate a report on Manufacturer here you have the option to either choose one manufacturer for whom you wish to generate a report. Alternatively, a report will be generated for all manufacturers if you do not select a specific manufacturer Status here you have the option to choose 1 of 4 options: expired, expiry date not provided, registered, under registration renewal 7

8 Quality standards here there are 2 options: WHO prequalification and SRA approved. You can select either one or both options as per the screen shot below.

Step 3: In addition to the regular search options, there is a box titled Display Columns see screen shot below. 9

Here there are 17 options (as per the screen shot below) that you can select for display in your report. If you do not select any of these options, the only information that will be shown in your report is the INN, strength and status. It is therefore important to select the reporting parameters. Brand name Manufacturer Country Country of manufacture Dosage form Dosage form detailed GFQA standard INN Manufacturer Manufacturing site Pack material Pack size Registration number SRA Status Strength WHO prequalification 10

Step 4: When you have selected all of your search options, click the Search tab. 11

12 A report will be automatically generated. If you want to start a new search, you must click the Rest Filters button see screen shot below. If you do not clear your previous searches, your new search will include the previous search criteria and your output will be incorrect

Step 5: If you want to export the report to Excel click on the floppy disc button (marked red in screen shot below) and then select from the pop up box the appropriate format you want. Click OK. 13

14 Step 6: For an advanced search, click on the top right hand side of the screen and key in your search criteria.

6. FREQUENTLY ASKED QUESTIONS 6.1 How often is the DSR data updated? The DRS is updated immediately when new registration data becomes available to AMDS. 6.2 What is the added value of the DRS? The DRS is a single source comprehensive mechanism whereby interested parties are able to access the global registration status of pharmaceutical products which are procured in low/ lower middle/upper middle income countries. Without the DRS, this information would not be available in the public domain. 6.3 Does the DRSD include pharmaceutical products used in the private sector market? The DRS focuses on pharmaceutical products which are required in the public sector. These products may equally be used in the private sector. 6.4 Can the DRS be expanded to include all essential medicines? In the future and subject to funding, the DRS can potentially be expanded to include the pharmaceutical product registration status of all essential medicines. However, this is not part of the existing scope of the project. Parties interested to see the project scope extended will need to convey this demand to AMDS. 6.5 Why is the pharmaceutical product registration period not specified in the DRS? This is considered to be commercial and proprietary information. 15

7. COMMUNICATION/VISIBILITY 7.1 Quarterly report WHO sends a quarterly report to all partners who are interested in being kept informed about DRS developments. If you would like to receive this report, please send an email to amds@who.int. 7.2 Feedback We welcome your feedback with respect to utilization of the DRS, including potential enhancements that you would like to see and any problems that you would like to have rectified. Please send your feedback to amds@who.int. 16

For more information, contact: World Health Organization Department of HIV/AIDS 20, avenue Appia 1211 Geneva 27 Switzerland ISBN 978 92 4 150505 5 E-mail: hiv-aids@who.int http://www.who.int/hiv/amds/