Japan Standard for Biological Ingredients: a supplier guide

The standard reaches every animal or human material in the process

The scope is wide. It is defined by where a material comes from, not by whether it ends up in the product.

The standard applies to raw materials derived from humans or other living organisms, plants excepted, that are used in drugs, quasi-drugs, cosmetics, medical devices and regenerative medical products. MHLW's text adds that this includes materials used in a manufacturing process as additives and culture medium components. Serum, trypsin, albumin, transferrin and growth factors all fall under it when they come from humans or animals. The standard does not apply to in vitro diagnostics and other products not used directly on the human body, nor to the microorganisms and viruses used to make vaccines.

The text is organized by origin. After general provisions come rules for blood products, then rules for human-derived materials (human cells and tissues, human urine, other human-derived materials), then rules for animal-derived materials. That last part holds the Standard for Ruminant-Derived Materials (反芻動物由来原料基準), rules for animal cells and tissues, and rules for other animal-derived materials.

It is not a new rule. It has been amended several times, including in 2014, when MHLW Notification No. 375 took effect on November 25, 2014 with a revised operational notice. Later revisions came in August 2023 and March 2026. PMDA publishes English provisional translations of the operational notice. The Japanese text prevails if the two differ. English sources also call it the Standards for Biological Raw Materials or the Criteria for Biological Ingredients.

List every component and processing aid of human or animal origin in each product you sell into Japan, because the standard follows the material's origin, not its role.

Ruminant materials: forbidden parts and permitted origins

For cattle and other ruminants, the standard is concrete. It names parts that may not be used and countries of origin that may.

MHLW's own summary puts it plainly: the ruminant section sets unusable parts and usable countries of origin, and the manufacture and sale of products using non-conforming materials is in principle prohibited. The same material notes why this matters for biologics: products made by cell culture often use ruminant materials, starting with bovine serum, in their media.

The country list has moved with BSE evidence. MHLW explained that it chose countries with reference to the European Food Safety Authority's geographical BSE risk assessment and US import restrictions. When EFSA reclassified Chile in 2005, MHLW removed Chile in 2007. A 2018 amendment (MHLW Notification No. 37 of 2018) allowed bovine placenta and spleen only from countries the World Organisation for Animal Health (then OIE) recognized as negligible BSE risk.

Origins can also come under scrutiny overnight. On April 13, 2018, MHLW reacted to chronic wasting disease, a transmissible spongiform encephalopathy of cervids, reported in a wild moose in Finland. It asked marketing authorization holders to self-inspect their use of cervid-derived materials from Finland by April 20, 2018, one week later. The notice treated products already on the market as not posing a public health risk under normal use, and said it would be reviewed as risk assessments came in. It defines the country of origin (原産国) as the place where the animals were born, raised or slaughtered.

Record keeping follows from this. MHLW's earlier BSE notices required companies to record and keep the manufacturer of a bovine material, the animals' country of origin and the parts used. A Japanese holder can only do that with the supplier's help.

Give every ruminant-derived component a documented country of origin (birth, raising and slaughter) and a named part, because a missing answer can block the customer's product.

March 2026: origin rules now point to WOAH status

The latest amendment changes how origin is judged. MHLW's revised operational notice of March 31, 2026 cites the instrument as MHLW Notification No. 155 of 2026, and says the revision reflects international trends and the latest science on the risk of transmitting the BSE agent.

The notice itself confirms the central change. Backbone and skull from cattle aged 30 months or younger, which were previously unusable, can now be used when the country of origin is one that the World Organisation for Animal Health (WOAH) recognizes as negligible BSE risk. The criteria for judging the country of origin were revised too.

Two further points rest on trade reports of the draft Japan notified to the World Trade Organization on January 23, 2026 (G/TBT/N/JPN/898) and of the final text, and we could not check them in MHLW's text. They say the amendment removes references to Canadian-origin materials and deletes country listings that duplicate WOAH's list. The same reports say the amendment took effect on release.

For suppliers, two things follow. First, a compliance statement that names a list of countries may no longer match the text the customer is checking against. Second, the source of truth for permitted origins is now partly outside Japan: WOAH's status list. A change in a country's WOAH status can change your answer without any Japanese notice.

MHLW revised its operational notice and its Q&A the same day. Draft-stage MHLW material also proposed clarifying that a drug already approved abroad, used as a raw material, may be treated as conforming even where full information cannot be gathered, weighing clinical experience and the severity of the target disease. Check the final Q&A before relying on that.

Rewrite your Japan compliance statement against the March 2026 text, citing WOAH status by date, and ask each Japanese customer which version its file refers to.

Cell banks and the history behind a material

The standard also reaches back in time. A cell line, a virus seed or a recombinant protein carries the history of the materials used to create it.

The industry has said so openly. Industry material published by AMED notes that master seeds and master cell banks made long ago for vaccines and viral vectors are in scope. Detailed information on the raw materials used to make them often cannot be obtained, which makes compliance hard to confirm.

The general route for a non-conforming material is a product-by-product risk assessment by the Council and a description in the approval. For old banks, MHLW added a simplified route in a 2009 administrative notice on medicines that use master cell banks or master seeds that do not meet the standard. It rested on the judgment that the theoretical risk from the materials used to create such a bank is extremely low, and a product that met six conditions was handled by the secretariat without a report to the Council. On March 31, 2026, MHLW abolished that notice, and revised the operational notice and the Q&A the same day. We have not read what they now say about old banks. Read them before you tell a customer that an old cell bank is acceptable.

Suppliers have already redesigned products around the standard. FUJIFILM Irvine Scientific reports that it modified an existing serum-free medium for mesenchymal stem cells to respond to requirements posed by PMDA. For materials used in regenerative medical products, the Master File guide explains how a supplier can register data with PMDA, and PMDA also runs a material suitability consultation for regenerative product materials.

For every cell line or seed behind your product, write down what is known about the animal and human materials used in its history, and say plainly what is not known.

What a Japanese customer will ask a supplier for

A Japanese holder has to show PMDA that its materials comply. For purchased materials, that evidence starts with the supplier, so your paperwork ends up in the holder's file.

The questions follow the standard's own headings. For each component of human or animal origin, expect to be asked for the species, the tissue or fluid, and the country of origin in the standard's sense. For ruminant materials, add the part used and, where it matters, the age of the animals. Expect questions about processing steps that reduce risk, and about the history of any cell line used to make a recombinant component. For human-derived components such as serum albumin, expect questions about the source material and the virus safety measures applied.

Two commitments matter as much as the data. The first is change notification. The Finland case shows how fast MHLW can ask holders to check an origin, with one week to complete the self-inspection, and a customer who learns of a source change months later may have a non-conforming product on the market. The second is traceability by lot, so that a question about one batch can be answered with that batch's origin, not a general statement.

In Proglenth's directory, the human serum albumin category is human-derived by definition, and categories such as cell dissociation enzymes and MSC culture media include products where these questions come up.

Offer Japanese customers a per-component origin statement tied to lot numbers, with a contractual promise to notify any change of species, tissue or country of origin before shipment.

Steps for a supplier selling into Japan

Take these in order. The first two usually take longest.

1. List every component and processing aid of human or animal origin in each product sold into Japan, including materials used to make recombinant components and to maintain production cell lines.
2. For each, record the species, tissue or fluid, country of origin (birth, raising and slaughter) and, for ruminants, the part used and the age of the animals where relevant.
3. Check ruminant components against the March 31, 2026 text (MHLW Notification No. 155 of 2026) and WOAH's current negligible BSE risk list, and note the date of the list you used.
4. Write down the known history of each cell line or seed behind your products, and mark the gaps.
5. Issue a dated Japan compliance statement per product, citing the version of the standard and WOAH status it relies on.
6. Add a clause to supply agreements with Japanese customers that commits you to notify any change in origin before the affected lots ship.
7. Review the statement whenever MHLW amends the standard or WOAH changes a country's status, and at least once a year.

For the Japanese terms on customer questionnaires, see the side box and the glossary.