| Autor: |
Cook R, Strand J, Schearer Sb |
| Rok vydání: |
1982 |
| Předmět: |
|
| Zdroj: |
Studies in Family Planning. 13:125 |
| ISSN: |
0039-3665 |
| DOI: |
10.2307/1965710 |
| Popis: |
Most Western countries have enacted regulatory laws on drugs and medical services and established regulatory authorities to review new products with respect to: 1) scientific data on the products quality safety and efficacy; 2) ability to acquire more information after the product is marketed; 3) ability to control usage after the product is marketed; and 4) ease of withdrawal of drug approval should the product prove to be a significant risk to the public. With contraceptive products the factors considered by drug regulatory authorities in risk/benefit assessment include: 1) overall utility of product to consumer 2) efficacy 3) side effects 4) evidence of safety 5) comparative risks of alternative contraceptive methods 6) consumer acceptability/convenience 7) product delivery requirements and 8) logistic requirements. Contraceptive availability is affected by local distribution (health care delivery distribution requirements formularies cultural and religious mores) and international distribution (export and import requirements). Regulations in developed countries have multiple effects: they can protect consumers in developing countries with inadequate technical and scientific capabilities for drug regulation against the sale of unsafe adulterated ineffective or misbranded products or they can cause unintended and sometimes undesirable restrictions. Standards or decisions in developed countries may not be appropriate to the health needs of a developing nation. It is recommended that regulatory policies in developed countries be reexamined to achieve a better balance between protecting the public and facilitating development of innovative contraceptive drugs and services. Among the recommendations in the report are more rapid review of drug applications international harmonization of certain regulatory guidelines or requirements closer professional collaboration between developed and developing countries possibly through WHO monitored or phased release of contraceptive products and better information for users. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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