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| Country Name | Geographical Region | Other Regional Group | Collaborative Recognition procedure (CRP) | Health Authority Name | HA contact information | Market Leader | Regulatory Agency Home page link | Ministry of Health home page link | Upcoming Regulation Flag | HA Guideline/Resolution/Regulation/ page link | HA Variation Guideline link page | HA Renewal Guideline link page | HA Registration Guideline link page | Reference Authority/Agency | Regulation Reference | SRA recognition Acceptability | WHO Pre Qualification (Member states) CRP | Procedure Type | application type | Application form | Products type | Regulatory Activity accepted | Country Filing Required | Duration of registration | Renewal required (Yes/No) | Submission Language | currency | CTA Fees | Scientific advice fees | application fees | Renewal Fess | variation fees | Line extension fees | Transfer fee | Drug Law original and fiest pulication date | Decree and regulation of reference Doc | Regulatory summery | National Pharmacopoeia | Edition last and current | Other Pharmacopoeia accepted | Pharmacopoeia website | CTD acceptability Yes/NO | eCTD acceptability Yes/No | Online electronic submission (agency portal, email address etc) | Electronic submission (CD/DVD/Pen drive) | climate zone | Long term (real time) testing condition | Minimum time period | time points (realtime) | Minimum number of bacth | accelrated testing condition | minimum time period (acc) | time point (ACC) | Intermedicate testing condition | minimum time period (INt) | time point (Int) | standard validation time for drug application | standard review time for drug application | priority/accelerated review approval availability | expected regulatory authority time – priority/accelerated | Language | MAH information | MA registration number | Mfg information | Mfg Date | Legal supply status | Price Details | Identification and Authenticity | traceability | GMP | GLP | GDP | GCP | GVP | CPP Issuing authority | WHO format | Turnaround time | Fees for COPP | Language | for which regulatory submission CPP required | need for legalization | Need for sample /label together with CPP submission | Area | Capital/Major City | Official language | Population | Description |
| Zambia | EEMEA | Southern African Development Community (SADC) | ZAZIBONA | Zambia Medicines Regulatory Authority | ZAMRA Head Office Zambia Medicines Regulatory Authority Plot No. 2350/M P. O Box 31890 Off Kenneth Kaunda International Airport Road Lusaka , Zambia Phone: +260 211 432 350 Phone: +260 211 432 351 | South africa | https://www.zamra.co.zm/ | https://www.moh.gov.zm/ | guidleine on tracibility of medicine | https://www.zamra.co.zm/guidelines/ | https://www.zamra.co.zm/wp-content/uploads/2023/08/Amendment-for-Marketing-Authorisation-Human-Medicines.pdf | https://www.zamra.co.zm/wp-content/uploads/2023/05/Guidelines-on-Renewal-for-Marketing-Authorisation-of-Medicines-and-Allied-Substances-ZAMRA_2019v2.docx | https://www.zamra.co.zm/wp-content/uploads/2023/08/Application-for-Marketing-Authorisation-CTD-Format-Human-Medicines.pdf | SADC | WHO, Thai Food and Drug Administration | Yes | Yes | national procedure | Finished Pharmaceutical products | Yes | Generic | Registration, renewal, Amendments | Yes | 5 Years | Yes | English | Zambian Kwacha | Human Clinical Trial Certificate involving Investigational Products without Marketing Authorisation – US$ 3,000.00, Human Clinical Trial Certificate involving Investigational Products with Marketing Authorisation – US$ 2,500.00 | US$ 400.00 | Generics- US$ 2,000.00, New Chemical Entities – US$ 2,800.00, Biologicals – US$ 2,800.00, Abridged Applications -US$ 1,700.00 | Human Medicines Generics, Human Medicines NCEs, Biologicals, – US$ 1,200.00, | Minor amendment – US$ 100.00, Major amendment – US$ 500.00 | Not specified | Not specified | the Medicines and Allied Substances Act No. 3 of 2013 | Not specified | The Zambia Medicines Regulatory Authority formally the Pharmaceutical Regulatory Authority is a Statutory National Medicines Regulatory Body in Zambia established under an Act of Parliament, the Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia to regulate and control the Manufacture, Importation, Storage, Distribution, Supply, Sale and Use of Medicines and Allied Substances. The main objective of the Authority is to ensure that all Medicines and Allied Substances being made available to the Zambian people consistently meet the set standards of Quality, Safety and Efficacy. The history of medicines regulation in Zambia dates back to 1941 when the Pharmacy and Poisons Act, Chapter 299 of the Laws of Zambia was first enacted. This Act was to provide for the control of the profession of pharmacy and trade in drugs and poisons. | Not specified | Not specified | BP,EP,USP,JP and Int Ph. | Not specified | Yes | No | No | Yes | Zone IVA: Hot/humid. •Zone IVB: Hot/very humid | 30/65 and 30/75 both accepted | 12 Months | first years every 3 months, then 2nd years every 6 month and after that yearly upto propose shelf life | 3 | 40/75 | 6 | 0,3,6 | Not required | Not required | Not required | Not specified | 9 months | yes | 3-6 months | English | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Not specified | Yes | Not specified | Not specified | Yes | Yes | Not specified | NO | English | Registration, renewal | NO | Yes | 7,52,618 | Lusaka | English | 1,70,94,130 | Zambia, officially the Republic of Zambia, is a landlocked country at the crossroads of Central, Southern and East Africa. It is typically referred to being in South-Central Africa or Southern Africa. It is bordered to the north by the … |