Market entry · Starting materials

Importing pharmaceutical starting materials and active ingredients

A finished medicine is only as reliable as the active pharmaceutical ingredients and excipients that go into it. WHO's guidelines on import procedures for medical products set out, in a short dedicated section, how starting materials are treated differently from finished products at the point of import, who carries responsibility for their quality, and what should travel with a consignment. For a manufacturer sourcing or supplying raw materials into a new market, that section is worth reading closely.

What counts as a starting material

WHO's guidelines define a starting material plainly: "any substance of defined quality used in the production of a medical product, but excluding packaging materials."¹ In the section dealing specifically with pharmaceuticals, WHO treats this as covering both active pharmaceutical ingredients (APIs) and excipients, the substances used alongside an API to produce the finished dosage form.¹ That is a broad definition. It puts a bulk API drum and a bag of excipient powder in the same regulatory category, and it is worth keeping in mind, because, as the next section shows, that category is not treated the same way a finished, marketed product is.

Who is responsible for their quality

WHO's guidelines are specific on where responsibility sits: "the responsibility for the quality assurance of starting materials ... used in that product is vested in the manufacturer of the finished pharmaceutical product."¹ In other words, the obligation to make sure an API or excipient is fit for use does not fall, by default, on a national regulator checking the material at the border. It falls on the company that buys the material and turns it into a finished medicine.

That is reinforced by a second point WHO makes in the same section: "few NRAs have introduced authorization requirements for APIs and excipients."¹ A finished, marketed medicine is generally registered with a national regulatory authority (NRA) before it can be sold. A starting material, in most places, is not put through an equivalent authorisation step of its own. The practical effect is that a manufacturer cannot assume a regulator has already vetted a raw material the way it would vet a finished product, and needs its own supplier qualification and testing to fill that gap.

Where authorities do step in at the border

That does not mean starting materials pass through customs unexamined everywhere. WHO's guidelines note: "some national and regional authorities also exercise documentary and (in some cases) quality control through laboratory testing of APIs as a prerequisite to customs clearance."¹ Two distinct things are described here. The first, documentary control, is a paperwork check, confirming that a consignment carries the records it is supposed to carry. The second, and WHO is careful to flag this as something only some authorities do, is actual laboratory testing of the API itself before release. A manufacturer moving raw materials into a given country should expect the level of scrutiny to vary, and should not assume that customs clearance in one market says anything about what will happen in another.

The paperwork that should travel with the consignment

On documentation, WHO's guidelines are concrete. Each imported pharmaceutical starting material "should be accompanied by a warranty (or batch certificate) prepared by the manufacturer," and WHO gives, as one example of how this can be organised, its own pharmaceutical starting materials certification scheme, referred to by the abbreviation SMACS.¹ Separately, where a starting material has been purchased and imported from a third-party vendor rather than directly from the original manufacturer, WHO's guidelines say it "should be appropriately labelled in accordance with national regulations and accompanied by a certificate of analysis from the original manufacturer."¹ Read together, these two points describe a documentation trail that is meant to run all the way back to the party that actually made the material, a manufacturer's warranty or batch certificate on one side, and a certificate of analysis from the original manufacturer on the other, even when a trading intermediary sits in between.

How this differs from a finished product's marketing authorisation

It helps to see the contrast with what happens to the finished product. WHO's guidelines define a marketing authorisation, also called a product licence or registration certificate, as "a legal document issued by the competent national regulatory authority that authorizes the marketing or free distribution of a medical product in the respective country after evaluation for safety, efficacy and quality," one that establishes the product's detailed composition and formulation, its quality requirements, and details of packaging, labelling, storage conditions, shelf life and approved conditions of use.¹ A starting material, as set out above, is generally not put through that same authorisation process on its own. Instead, its quality is folded into the finished product's dossier by the manufacturer who used it, which is precisely why WHO places the quality assurance burden on that manufacturer rather than on a border check of the raw material.

What this means for entering the Yemen market

This is the general international framework WHO describes, not a Yemen specific checklist, and it will not tell a supplier of starting materials exactly which documents Yemen's authority currently asks for on a given shipment. That detail is confirmed case by case with the authority. LNJC is a licensed importer and distributor of pharmaceuticals, medical supplies, laboratory equipment, pharmaceutical raw materials and packaging materials in the Republic of Yemen, based in Sana'a, and is happy to talk through what a specific raw material category currently needs.

In summary

WHO's guidelines treat pharmaceutical starting materials as a distinct category from finished medical products. Their quality assurance is the finished-product manufacturer's responsibility, few regulators authorise APIs and excipients directly, and border checks range from documentary review to laboratory testing depending on the country. What should travel with every consignment is a manufacturer's warranty or batch certificate, and, where a third-party vendor is involved, a certificate of analysis from the original manufacturer. A supplier or buyer who keeps that documentation trail intact is meeting the standard WHO describes, wherever the shipment is headed.

See also: how medical products are cleared for import, the wider framework this same WHO guidance sets out for customs.