Voluntary ADR reporting – Country specific Regulatory Authorities

The Spontaneous/voluntary adverse drug reaction reporting structure is the voluntary and the most common way through which the regulatory bodies collect ADR information for medicines once they are on the market.

Who should report?

• Healthcare Professionals are the preferred source of information in pharmacovigilance, for example physicians, family practitioners, medical specialists, and dentists.
• Nurses and other health workers may also administer medicines and should report relevant adverse drug reactions experienced by the patients.
• Pharmacists can play an important role in the stimulation of reporting and in the provision of additional information (for example, on co-medication and previous medicine use).
• Patients & their relatives can also report their experienced adverse drug reactions directly to Regulatory Authorities, or through their healthcare professionals.

Click on below link based on your country to report Adverse events associated with pharmaceutical products.

• Australia TGA
• India – Pharmacovigilance Programme of India
• United States of America – MedWatch Online Voluntary Reporting
• United Kingdom – Yellow card
• Germany – BfArM
• China – National centre for ADR reporting
• Canada – Health Canada
• Austria – Austrian federal office for safety in Healthcare (BASG)
• Armenia: Drug and Medical Technology Agency 
• Belgium – The Belgium national competent authority
• Czech Republic – The state institute for drug control
• Croatia – The Agency for medicinal products and medical devices (HALMED)
• France – French national agency for medicines and health products safety (ANSM)
• Denmark – The Danish Medicines Agency
• Ethiopia – Ethiopian Food and Drug Authority
• Finland – Finnish Medicines Agency (FIMEA)
• Greece- National Drug Organisation for Medicines (EOF)
• Estonia – The Estonian State Agency of Medicines (SAM)
• Hungary – National institute of Pharmacy and Nutrition (OGYEI)
• Iceland- The Icelandic Medicines Agency
• Ireland – Health Products Regulatory Authority (HPRA)
• Italy – The Italian Medicines Agency (AIFA)
• Sweden – Swedish Medicinal Products Agency (MPA)
• Japan – Pharmaceuticals and Medical device Agency (PMDA)
• Jordan – JFDA
• New Zealand – MEDSAFE
• Malaysia – National Pharmaceutical Regulatory Agency (NPRA)
• Norway – Norwegian Medicines agency (NoMA)
• Portugal – The Portuguese National Authority on Medicines and Health Products (INFARMED)
• Romania – National Agency for Medicines and Medical Devices (NAMMD)
• Mauritius – National Pharmacovigilance Committee
• Lithuania – The State Medicines Control Agency of Lithuania
• Singapore- Health Science Agency (HSA)
• Slovakia – The State Agency of Slovakia (SUKL)
• Slovenia – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
• Spain – The Spanish Agency of Medicines and Medical devices (AEMPS)
• South Korea – The Korea Institute of Drug Safety and Risk Management (KIDS)

Characteristics of good case report: The quality of the reports is critical for appropriate evaluation of the relationship between the product and adverse reactions, thus good case reports include the following elements:

1. Description of the adverse reaction or disease experience, including time to onset of signs or symptoms and the seriousness of the reaction/s;
2. Suspected and concomitant medicines details (i.e., Name, concentration, dose, dosage form, rout of administration, indication for use, duration of use& batch number especially for vaccines), including over-the-counter medications, dietary supplements, and recently discontinued medications;
3. Patient characteristics, including the name or initials, age, sex, weight, and baseline medical condition prior to product therapy, co-morbid conditions, use of concomitant medications, relevant family history of disease, and presence of other risk factors;
4. Documentation of the diagnosis of the reactions, including methods used to make the diagnosis;
5. Clinical course of the reaction and patient outcomes (e.g., hospitalization or death);
6. Relevant therapeutic measures and laboratory data at baseline, during therapy, and subsequent to therapy, including blood levels, as appropriate;
7. Information about response to dechallenge and rechallenge; and
8. Any other relevant information (e.g., other details relating to the reaction or information on benefits received by the patient, if important to the assessment of the reaction).
9. The minimum information which allows the case report to be valid subsequently to be entered onto the national ADR database and become available for signal generation in order to facilitate evaluation of cases.
10. When one or more of these information are missing, the case should be followed up in order to validate the report and complete its processing as described above.