Generic Drug Approval Process In Laos
Lao People’s Democratic Republic (PDR) government is giving the highest priority to the healthcare sector, and this is creating a good opportunity for foreign country manufacturers like Indian and China to export low-cost high-quality generic drugs into Laos.
Lao’s is a small country with a very small market for medical, health, and other pharmaceuticals. The healthcare provided at the local level often struggles from a lack of qualified staff, inadequate infrastructure, and the need for an affordable device and drug supply.
The Laotian government maintains a separate healthcare program for different income groups such as
- The State Authority for Social Security (SASS) for civil servants,
- The Social Security Office (SSO) for employees of state and private enterprises,
- The Community-based Health Insurance (CBHI) for informal-sector workers,
- The Health Equity Funds (HEFs) for the poor, and
- Free maternal and child health services in selected provinces.
So Laos depends on international aid in vaccination, training for medical professionals and staff, and strengthening maternal and child health.
The country offers a significant opportunity for generic products. Moreover, the government has also come up with offers and incentives for investments in the field of pharma sectors for promoting the health of the public.
What is a generic drug product in Laos?
A generic medicinal product is a drug product that has the same qualitative and quantitative composition in active substances and the same dosage form as the medicinal product, and whose bioequivalence with the comparator medicinal product has been demonstrated by appropriate bioavailability studies.
The regulators consider active substances with different salts, esters, ethers, isomers, mixtures of isomers, complexes, or derivatives of an active substance to be the same active substance unless they differ significantly in properties concerning safety and/or efficacy.
Regulatory authority for drug approval in Laos
The Food and Drug Department (FDD) is the regulatory authority in Laos and regulates pharmaceuticals and medical devices.
The manufacturer shall register the drugs and medical products with the (Ministry of Health) MOH to sell in Laos. The MOH is required to issue a certificate stating the drug conforms to legal health standards.
MOH must inspect and analyze drugs and medical products to determine whether they conform to established safety and efficacy standards, prior to registration.
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Drug approval process in Laos
Drug registration committees appointed by MOH decide whether a drug is eligible to register in Laos. The consideration period is within 180 days. The Food and Drug Department (FDD) issues a drug registration number and certificate for any approved drug, authorizing the license holder to manufacture or import.
Medicinal product registration in Laos usually takes approximately six months once FDD confirms the application and receives all supporting documents. For the drug samples, the authority grants the import permission before the drug registration certificate is issued.
The applicant should supply the reference substances for analysis when needed. For approved drugs, product owners (i.e., manufacturers, importers, or exporters) must print the registration number on the labels, boxes, containers, blisters, vials, etc. For imported drugs, the applicant can produce a Lao version leaflet if there is no possibility to print the Lao content on the label.
Bioavailability (BA)/Bioequivalence (BE) study requirements
For modified-release products, dosage recommendations, and regime, the sponsor needs to submit bioavailability studies. Studies comparing availability or establishing equivalence of similar products would be required.
In applications for generic medicinal products, the concept of bioequivalence is fundamental. The regulatory authority waves bioequivalence studies for some categories of products.
Requirements for manufacturing site
Manufacturing companies or the exporting parent companies shall hold a proper license of the related countries, and export through a representative, which is a licensed local company for importing generic drug products, or a representative office of the mother company in Lao PDR with the authorization for the performance as agreed by both mentioned parties is mandatory.
- Manufacturers intending to manufacture drugs shall submit applications for producing drug samples by Form No. 1 of the prescribed guidelines.
- After the approval of drug samples, within 3 to 6 months, the manufacture shall apply for registration using form No. 2 as per the prescribed guidelines.
Requirements for foreign manufacturers
- Foreign manufacturers who do not have a local entity can engage a local representative or licensed local company to import generic drugs into Laos.
- Local and foreign business investors can obtain a license to conduct business such as import, export, distribution, wholesale, and manufacture of medicines and medical products/devices.
- Individual/person who intends to import drugs shall apply to import drug samples under Form No. 1 of the prescribed guidelines.
- After the approval of drug samples, within 3 to 6 months, the manufacture shall apply for registration under form No. 2 of the prescribed guidelines.
Review fees for generic applications
The product owner applying for drug registration shall pay the following fees
- Specific professional service fees, application forms, and supporting documents.
- Quality control fees or fee for Post-marketing surveillance;
- Fees for drug registration:
The fee ranges from 30 US$/ to 100 US$/ per item
Review timelines of generic drug approval in Laos
- Medicinal product registration in Laos usually takes six months once FDD confirms the application and receives all supporting documents.
- For drug samples, the sponsor needs to obtain an import permit before the authority issues the drug registration certificate.
Post-approval distribution process
All medicines that will be distributed in Laos must be registered with the Food and Drug Department. For any drug registered in Lao PDR, only the authorized applicant shall be entitled to import that drug. The Food and Drug Department will issue a registration number and a certificate of drug registration for any drug which is approved for registration, thereof the license shall be entitled to manufacture, and import as well.
In the case that drugs are not needed to perform a laboratory test, before issuing the certificate of drug registration, the sample of drugs should be taken in time of importation.
For every imported drug if there is no, possibility to print the necessary Lao content on the label, the related importing and distributing company shall prepare the leaflet in Lao version which shall be inserted into all different types of packages before distributing.
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- Regulation Governing Drug Registration, No. 1441/MOH, Lao People’s Democratic Republic