A. Office Space and Equipment
• Computer room: The room should be at least 12 square metres with tables and shelves to store reference books and files under consideration. It should be a climate-controlled, secure room that is not susceptible to leaks or flooding. This room should be used for the server computer in a networked office, or the primary computers in a non-networked office.
• Room where applications are received: This room should be at least 12 square metres with a desk to receive people submitting applications and to provide information, forms, and materials. It should also have tables and shelves to store reference materials and files before distribution for assessment, and shelves or cupboards to temporarily store samples and packaging.
• Waiting room: The room should be at least 12 square metres with a sitting area and, on the walls, instructions for applicants (e.g., a list of documents to submit for each type of application).
• File room: This room should be at least 50 square metres with a desk and shelves to store files after assessment is completed and decision published. Files are stored by an established criterion, e.g., registration number, product name, or MA holder name in alphabetical order.
• Staff offices: If there are separate offices, they should have desks with a computer terminal.
• Computers/Printers: At least two computers, one dedicated to the drug registration software system, and one for correspondence and other purposes, should be available. The minimum recommended specifications for these computers are: 486 processor, 4 MB of RAM, and 100 MB of free hard drive space. At least one printer should also be available for use with the drug registration software system.
An experienced pharmacist or medical doctor with special training and experience in assessing MA applications should be appointed as team leader/chief/director. At least two additional technical professionals should be assigned to assess applications, prepare reports, and propose final decisions. An appropriate number of support staff should also be assigned to the DRA.
C. Legislation, Regulations, Guidelines, Instructions
Several updated copies of all relevant legislation, regulations, and other written materials should be reliably available (at least one per technical professional staff, plus spare copies to permit on-site public consultation).
D. Reference Books and Manuals
The following materials should be available, in numbers proportionate to the size of the staff:
• Software package user manuals
• Lists and criteria for definitions, abbreviations, and codes used in the recording of information and decisions made during assessment of applications
• Reference books. At least the following should be reliably available:
- INN Cumulative List, Color Index, Merck Index, and Martindale to help identify active and inactive substance names. These do not waive applicant’s obligation to submit source of substance names used in applications.
- Books and/or compact disks publishing approved product information in reference countries, e.g., USP-Dispensing Information, British National Formulary, Vidal, to help assess product information (indications, contraindications, adverse effects, etc.). These do not waive applicant’s obligation to submit, in the case of imported products, or products also marketed in other countries, an up to date certificate providing the same information as in the WHO Certification Scheme.
E. Administrative Tools
- new drug applications log
- renewal applications log
- variation applications log
- MAs log
- national essential drugs list
- hospital use only drug list
- other special lists as appropriate
• Model certificates and correspondence:
- revised MA
- letter informing of rejection of application
- letter informing of cancellation of/variation to MA
- letter requesting additional information/documentation to support application
- application follow-up form
- WHO-type product certificate
- other forms/letters as applicable
• MAs and revised MAs should include at least:
- product name
- dosage form
- dosage strength
- primary container
- MA holder name and address
- name and address of final manufacturer
- approved names and quantities of active ingredients
- approved names and quantities of inactive ingredients that may be of concern for a number of potential consumers (e.g., tartrazine, ethanol, saccharose)
- approved product information (i.e., indications, mode of administration, contraindications, adverse reactions, precautions, use in children/elderly/pregnancy/other special situations (if any), food and drug interactions)
- shelf life and storage conditions
- registration number
• Application folder An application folder should be used to keep:
- copy of MA in other countries, WHO-type certificate, any other required certificate
- proposed price and proof of price in other countries
- receipt of payment of application fee
- technical documentation supporting application
- reports prepared by regulatory staff or external experts during assessment
- report of national quality control laboratory, where applicable
- any other documentation concerning the application and its assessment
F. Written Working Procedures
There should be written working procedures available at least for the following items:
• Reception, classification, and numbering of applications
• Preparation of application folder
• Recording of application data into computer system
• Distribution of application, or parts of it, to those in charge of its assessment
• Assessment criteria, guidelines, and procedures
• Preparation of assessment reports
• Preparation of decision proposal
• Communications with applicants